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Current Drug Shortages

Posted Jun 22 2010 5:52am
Drug Name Company
Information
Reason for Shortage Related Information

Acyclovir Tablets and Capsules

updated
5/21/2010

Teva Pharmaceuticals
1-800-545-8800

GlaxoSmithKline
1-888-825-5249

Mylan Pharmaceuticals
1-800-796-9526


Carlsbad Technologies, Inc.
1-760-431-8284

Manufacturing Delays

Increased Demand

Pending site transfer

Increased Demand

Teva is releasing acyclovir tablets as they become available.

GlaxoSmithKline has Zovirax 400 mg tablets (NDC 00173-0949-55), and 800 mg tablets (NDC 00173-0945-55) available.

Mylan anticipates having Acyclovir Tablets and Capsules available in late May/early June.
Acyclovir Capsules USP, 200 mg, Bottles of 100, NDC 0378-2200-01
Acyclovir Capsules USP, 200 mg, Bottles of 500, NDC 0378-2200-05
Acyclovir Tablets USP, 400 mg, Bottles of 100, NDC 0378-0253-01
Acyclovir Tablets USP, 400 mg, Bottles of 500, NDC 0378-0253-05
Acyclovir Tablets USP, 800 mg, Bottles of 100 NDC 0378-0302-01
Acyclovir Tablets USP, 800 mg, Bottles of 500, NDC 0378-0302-05

Carlsbad has limited supplies available for the following Acyclovir packaging sizes:
NDC: 61442-111-01 Acyclovir Capsule 200 mg/100count bottles

NDC: 61442-112-01 Acyclovir Tablet 400 mg/100count bottles

NDC: 61442-113-01 Acyclovir Tablet 800 mg/100count bottles

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%

9/18/2008

Ucyclyd Pharma, Inc. 1-888-829-2593, or 1-800-900-6389 with a representative available 24 hours, seven days a week. See information in Related Information section.

Limited supplies continue to be available.

Please see attached DHP letter for important safety information.

Dear Healthcare Professional  

Atracurium injection

4/29/2010

Bedford
Customer service
1- 800-562-4797
Manufacturing delays This has been an ongoing shortage that Bedford has been working to resolve and the firm anticipates availability by late May 2010 for 5 ml and 10 ml vials.

Azactam 1 gram and 2 gram (aztreonam for injection)

updated
3/23/2010

BMS
1-800-332-2056

Baxter
1-888-229-0001

Manufacturing delays

BMS has no information regarding dates of availability of Azactam 1 gram vials (NDC 51479-0041-15), and 2 gram vials (NDC 51479-0042-15) at this time.

Baxter has 1 gram (NDC 51479-0048-01) and 2 gram (NDC 51479-0049-01) frozen aztreonam available.  For additional information call Baxter at 1-888-229-0001.

Cerezyme (imiglucerase) Injection

updated
3/2/2010

Genzyme Corporation

For inquiries contact Genzyme Medical Information: medinfo@genzyme.com or 1-800-745-4447, option 2

Manufacturing delays

Please see Dear Doctor letter , Dear Patient letter , and Request Form also visit the Website:  Genzyme supply update for additional information.

VPRIV (velaglucerase alfa for injection) has received FDA approval and is now available from Shire Human Genetic Therapies, Inc.  For additional information please contact Shire at: ONEPATH , or by phone at 1-866-888-0660.

Please see the following link: Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease for information about prGCD, also called Taliglucerase Alfa (this is a treatment protocol available under IND

Please see Dear Doctor letter regarding Zavesca (miglustat) as an immediate option for patients
who may not have access to imiglucerase treatment during the shortage

Dear Health Care Practitioner Letter (PDF - 121KB)

Cleviprex 0.5 mg/mL 50 mL vial (NDC 65293-0002-50) 100 mL vial (NDC 65293-0002-00)

3/22/2010

The Medicines Company See Related Information Section Please visit: Recall -- Firm Press Release regarding recall of certain lots that may contain particulate matter. No information at this time regarding when the product will be available.

Ephedrine Injection

2/25/2010

Hospira
1-877-946-7747

Sandoz (formerly Parenta)
1-800-525-8747

Akorn Pharmaceuticals
1-800-932-5676

Manufacturing delays.

Increase in demand.

Hospira will have a delivery of Ephedrine available in mid March. Hospira will have not have additional deliveries until May, at which time we will resume regular deliveries. (NDC 00409-3073-31)

Parenta is releasing product as it becomes available and estimate that the backorder will be resolved mid-March 2010. (NDC 66758-0008-02)

Akorn has product available and continues to release. (NDC 17478-0515-00)

Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34)


6/4/2010

Hospira Inc.,
1-877-946-7747
Unanticipated increased demand

Hospira is working to increase production to respond to the increased demand and plans to have releases by end of June with additional releases in July and beyond. 

Please see the American Society of Health Systems Pharmacists link below for important safety information regarding the use of alternate epinephrine injectables during the shortage: Epinephrine 0.1 mg/mL Emergency Syringes Exit Disclaimer

Ethiodol (ETHIODIZED OIL) ampules

updated
6/10/2010

Guerbet LLC
Customer Service
(1-877-729-6679)
Product has been discontinued by Nycomed US Inc. Guerbet has acquired the Ethiodol NDA from Nycomed US Inc. effective May 7, 2010 and is working with FDA to resume manufacturing of Ethiodol in the near future to ensure continued availability for the US patients. During this interim period, Guerbet, in conjunction with the FDA, is initiating a temporary importation of LIPIODOL ULTRA-FLUIDE, ethyl esters of iodized fatty acids of poppy seed oil, to the United States market. See Dear Healthcare Professional Letter (PDF - 325KB) for additional information.
(Letter updated 6/10/2010)

Fabrazyme (agalsidase beta)

updated
12/2/2009

Genzyme Corporation

For inquiries contact Genzyme Medical Information: medinfo@genzyme.com or 800-745-4447, option 2

Manufacturing delays

Please see Dear Doctor Letter (PDF - 26KB) for additional information.

For information on other treatment options see: Drug shortage for Fabrazyme

Visit Web site: Genzyme supply update

Dear Health Care Practitioner Letter (PDF - 121KB)

Fosphenytoin Sodium Injection

updated
5/21/2010

Bedford Laboratories
1-800-562-4797

Hospira
1-877-946-7747

Akorn Pharmaceuticals
1-800-932-5676

APP
1-888-386-1300

Not currently marketed.

Manufacturing delays.

Not currently marketed.

Increase in demand.

Bedford will be off the market for an undefined period of time.

Hospira anticipates releasing product in July/August.

Akorn will be off the market for an undefined period of time.

APP continues to release product as it becomes available.

Furosemide Injection 10mg/ml

New!
6/22/2010

Hospira Inc.
1-877-946-7747

American Regent, Inc.
1-800-645-1706

APP
1-888-386-1300

Manufacturing delays

Increase in demand

Increase in demand

Hospira is allocating all the presentations to help manage the backorder situation and is working to restore adequate supply.

Product on backorder. American Regent, Inc., the distributor of Furosemide Injection, USP 10 mg/mL manufactured by Luitpold Pharmaceuticals, Inc., has and will continue to notify its wholesalers of the product release dates for all three presentations of Furosemide Injection, USP 10 mg/mL (2 mL vial, 4 mL in a 5 mL vial and 10 mL vial) so they can communicate product availability and appropriately allocate to the end user.

APP is increasing production to meet market demands. Currently, APP is allocating furosemide 10 mg/mL in 2ml injection (NDC 63323-0280-02) for emergencies only and anticipate additional batch releases mid July. APP is currently back-ordered on furosemide 10 mg/mL in 4ml injection (NDC 63323-0280-04) vials and anticipating multiple batch releases the week of June 28.

Haloperidol Decanoate Injection

New!
6/18/2010

Teva Pharmaceuticals
1-800-545-8800

Ortho-McNeil Janssen
1-800-526-7736

APP Pharmaceuticals
1-888-386-1300

Bedford Laboratories Customer Service
1-800-562-4797

Manufacturing delays

See Related Information

See Related Information

Manufacturing delays

Teva has all presentation on back order with an estimated release date of November of 2010.

Ortho-McNeil has Haldol Decanoate available in 50 mg/mL 1 mL ampoules in 3 count (NDC 00045-0253-03) presentations and 100 mg/mL 1 mL ampoules (NDC 00045-0254-14).

APP has haloperidol decanoate available in 50 mg/mL 1 mL vials (NDC 63323-0469-01), 50 mg/mL 5 mL vials (NDC 63323-0469-05), 100 mg/mL 1mL vials (NDC 63323-0471-01), and 100 mg/mL 5 mL vials (NDC 63323-0471-05). The dating on the haloperidol decanoate 50 mg/mL 1 mL is 8 months. Additional batches of 100 mg/mL 1mL and 50 mg/mL 5 mL will be available late-June.

Bedford has on allocation haloperidol decanoate 50 mg/mL 1 mL vials (NDC 55390-0412-01). All other presenations are on back order and expected to be available in the next 1-2 months.

Heparin Sodium Large Volume Premixed Infusion Solutions

updated
6/22/2010

B. Braun
1-800- 227-2862

Baxter
1-888-229-0001

Hospira
1-877-946-7747

Shortage of Heparin Sodium drug substance that meets current qualification requirements

Shortage of finished product that meets current specification.

Short supply of drug substance and unanticipated issues to implement the new USP Heparin monograph.

B. Braun is working to resolve the issues that have led to the shortage. B. Braun estimates that the back-order will be resolved by mid-June, and has all large volume heparin infusion solutions available on allocation.

Baxter is working  to resolve the issues that have led to the shortage but there is not yet a timeline reported for availability.  Baxter continues to have available their heparin sodium 1000u/500 ml in 0.9% Sodium Chloride and heparin sodium 2000u/1000ml in 0.9% Sodium Chloride. Please see Dear Valued Baxter Customer Letter (PDF - 87KB)

Hospira has all large volume heparin infusion solutions available on allocation.

Please also note that APP continues to have all high dose heparin sodium injectable vials available including those vials suitable for compounding large volume infusion solutions; heparin sodium 50,000U/10mL NDC# 63323-0047-10 and heparin sodium 50,000U/5mL NDC# 63323-0542-07 vials.  For additional product questions please call APP Customer Service at 1-888-386-1300

Intron A (interferon alfa-2b, recombinant) Solution in Multidose Pens for injection

11/24/2009

Schering-Plough (customer service number) 1-800-222-7579 Please see attached Recall Letter

The other Intron A presentations (powder for solution and multiple dose vials) remain available at this time.

Intron MDP Recall Letter (PDF - 205KB)

Isoniazid Injection (NDC 00781-3056-70)

5/19/2009

Sandoz (customer service number)
1-800-525-8747

Product continues to be available with short expiration dating. Sandoz has continued to make isoniazid injection available and the product may be ordered through wholesalers.

Leucovorin Calcium Lyophilized Powder for Injection

New!
6/18/2010

Bedford Laboratories
Customer Service
1-800-562-4797

Teva Pharmaceuticals
1-800-545-8800

Manufacturing delays

Manufacturing delays

Bedford has available leucovorin calcium lyophilized powder for injection 50 mg (NDC 55390-0051-10) and 200 mg (NDC 55390-0053-01) vials. All other presentations are on back order with estimated release dates in July and August, 2010.

Teva has all presentations on back order with an estimated release date the week of June 28, 2010.

Levorphanol 2mg Tablets

4/8/2010

Roxane Laboratories
1-614-276-4000
Manufacturing delays. Product anticipated to be available in July.

Mexiletine Capsules (150mg, 200mg, and 250mg)

updated
5/21/2010

Teva Pharmaceuticals
1-800-545-8800
Manufacturing Delays Teva has 150 mg capsules (NDC 00093-8739-01) available. 200 mg capsules and 250mg capsules are anticipated to be available by end of May 2010.

Mitomycin for injection


updated
5/21/2010

Ben Venue

Accord Healthcare Inc.

Manufacturing delays

Ben Venue (Bedford) has emergency supplies available. Ben Venue customer service: 1-800-562-4797.

Accord plans the 20mg vials to be released by end of May and the 5mg vials to be released in June.

Mustargen (mechlorethamine HCl) injection

updated
5/21/2010

Lundbeck Inc.
Customer service number:
1-888-514-5204
See Related Information

Contractor will no longer pursue commercial manufacturing. Lundbeck is working to transfer to a new manufacturing site.

Currently a limited amount of Mustargen is available with a September 2010 expiration date and this will be distributed by Lundbeck to meet patient needs (pharmacies will need to call their wholesaler to obtain quantities of Mustargen to meet patient needs. 

Once the limited supply runs out there is anticipated to be a shortage until product is available from a new manufacturing site and FDA is working closely with Lundbeck to make this happen as soon as possible. 

Current projections from Lundbeck are that new Mustargen product may not be available until end of 2010 but we are continuing to work with Lundbeck and updates will be provided as they become available.

Please see the Dear Healthcare Professional Letter (PDF - 24KB) from Lundbeck for additional information.

MVI injectable (Adult and pediatric)

updated
5/28/2010

Hospira
1-877-946-7747

Baxter (Infuvite adult and pediatric IV solution)
Customer Service:
1-888-229-0001

Manufacturing delays relative to all adult formulations; Hospira is working to restore adequate supply, however, no timing is available.

Increase in demand

MVI Pediatric 5mL Single Dose Vial (NDC 61703-421-53): Product is in adequate supply.

Infuvite both adult and pediatric IV solution remains available from Baxter

Naloxone Injection

New!
6/22/2010

Amphastar 
1-800-423-4136

Hospira 
1-877-946-7747

See related information section

Manufacturing delays

Amphastar-IMS has available naloxone 1 mg/mL 2 mL syringes with needles (NDC 0548-1469-00) or without needles (NDC 0548-3369-00).

Hospira has all naloxone 0.4 mg/mL presentations on back order, however, the company expects to clear all backorders by late June, 2010, with full recovery (reach target inventory position) by end of July, 2010.

Neupro (rotigotine transdermal system)

updated
5/5/2010

UCB, Inc
800-477-7877
UCB has recalled all domestic lots

FDA has requested that UCB reformulate Neupro (rotigotine transdermal system) patches. UCB is committed to bringing Neupro to U.S. patients and has already made significant progress in the development of the new formulation.

If you have additional questions about the status of Neupro, or about UCB’s Patient Access program for Neupro, please contact UCB Medical Information at 1-866-822-0068 (option 9).

Nimbex (cisatracurium) injection

updated
5/21/2010

Abbott Laboratories
1-800-255-5162
Unexpected Increased Demand and Manufacturing Delays

Abbott expects sporadic inventory availability through June 2010. Abbott advises that due to increased demand for Nimbex (cisatracurium), it is advisable to place orders at your wholesaler before the expected delivery dates to improve likelihood of inventory procurement.

Oxsoralen (methoxsalen) 1% topical lotion

3/17/2010

Valeant Pharmaceuticals International
1-866-819-9007

Manufacturing delays

This has been an ongoing shortage which is anticipated to be resolved by July 2010 - any updated information will be posted as soon as it is available.

Oxsoralen-Ultra (methoxsalen) 10 mg capsules

updated
6/17/2010

Valeant Pharmaceuticals International
Customer Service
1-800-556-1937

Manufacturing delays

Valeant has released limited quantity of Oxsoralen-Ultra 10mg capsules to the market and is committed to ensuring the product is allocated properly to patients in need. Please see the Dear Healthcare Professional Letter (PDF - 49KB) for additional information.

You may also contact Valeant by e-mail at pharmcs@valeant.com for additional information.

Pancuronium Injection

New!
5/24/2010

Teva Pharmaceuticals
1-800-545-8800

Hospira
1-877-946-7747

Teva initiated withdrawal of multiple lots of pancuronium injection from the market on 5/4/2010.

Increased demand

Teva has no immediate plans to re-enter the market

Hospira has pancuronium 1 mg/mL, 10 mL vial, package of 25 (NDC 00409-4646-01) on backorder due to increased demand and is working to meet demand. Sufficient inventory is expected by late June.

Pentothal (thiopental) Injection

updated
3/25/2010

Hospira Pharmaceuticals
1-877-946-7747
Manufacturing issue Hospira is working to resume availability of this product in 2010.

Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s


updated
6/10/2010

Teva Pharmaceuticals
1-800-545-8800

Hospira Inc.
1-877-946-7747

APP
1-888-386-1300

Teva Pharmaceuticals has discontinued their propofol injection.

Hospira Inc. recalled specific lots because some containers may contain particulate matter. Hospira has implemented improvements to its manufacturing process and is coordinating with the FDA to begin distribution of propofol manufactured under a new process as soon as possible.

APP has increased production in response to the increased demand. Please see additional information on availability in the Related Information section

Additional Information on Propofol Supplies

Questions and Answers on the Propofol Shortage

Please see the Dear Health Care Professional Letter (PDF - 41KB) from APP.

Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP)

New!
5/24/2010

Teva Pharmaceuticals
1-800-545-8800
Teva recalled Lot #31308526B/Exp. Date 9/2012 of SMX/TMP Injection 10 ml vials to the retail level because some vials may have defective crimps. All sizes of vials are currently unavailable. Teva plans availability of the 30 ml vials (NDC 00703-9526-01) in July 2010. The 5 ml (NDC 00703-9503-03); and 10 ml vials (NDC 00703-9514-03) are anticipated to be in adequate supply in August 2010.
Technetium Tc99m Generators

updated
6/8/2010

Covidien:
1-888-744-1414
(Ultra-Technekow DTE, NDA 17-243)

Lantheus:
1-800-299-3431
(Technelite, NDA 17-771)

Reduced supply due to material sourcing issues. Technetium-99m Radiopharmaceutical Product Shortage

Thyrogen (thyrotropin alfa) injection 1.1 mg/vial

New! 
5/24/2010

Genzyme Corporation - for inquiries contact Genzyme Medical Information: medinfo@genzyme.com or 1-800-745-4447, option 2 Please see information in Related Information section. CDER Statement to Healthcare Professionals: Restricted Availability of Thyrogen

Thyroid (desiccated) tablets

2/12/2010

Forest
RLC
Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. This has been a long term shortage and any new information will be posted as soon as it becomes available. FDA approved levothyroxine products continue to be available from multiple manufacturers.

Thyrolar Tablets

12/31/2009

Forest Pharmaceuticals Manufacturing delays Forest has not yet reported when Thyrolar will be available.

Vecuronium Injection

updated
5/24/2010

Bedford Laboratories Customer Service
1-800-562-4797

Sun Pharmaceutical Industries, Inc.
1-800-818-4555

Teva Pharmaceuticals
1-800-545-8800

Hospira, Inc.
1-877-946-7747

Increase in demand


Increase in demand

On manufacturing hold

Manufacturing Delays

Bedford is releasing 10 mg vials, package of 10 (NDC 55390-0037-10) and 20 mg vials, package of 10 (NDC 55390-0039-10) as product becomes available.

Sun Pharmaceutical Industries (Distributor: Caraco Pharmaceutical Labs, Ltd.) is continuing to release product as it becomes available.
Vecuronium Bromide for Injection 10 mg 10 vials NDC 41616-0931-44
Vecuronium Bromide for Injection 20 mg 10 vials NDC 41616-0932-44

Teva has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on backorder and supply is anticipated to be available in September.

Hospira will be off-market for an undefined period.

    

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