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Class II: temporary or reversible health riskTerminated

Teva Pharmaceuticals BUPRENORPHINE HYDROCHLORIDE Sublingual Recall

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva P…

Teva Pharmaceuticals USA · North Wales, PA

Risk level
Class II
Reported by FDA
May 28, 2014
Recall ID
D-1324-2014
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled BUPRENORPHINE HYDROCHLORIDE Sublingual starting Apr 7, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1324-2014 on May 28, 2014. Reason: Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

Product description

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.

Lot numbers, UPCs & expiration codes

Lot #: 34013132A, 34013133A, 34013134A, 34013135A, 34013136A, Exp 11/14

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1324-2014
Classification
Class II
Status
Terminated
Recall initiated
Apr 7, 2014
FDA report date
May 28, 2014
Quantity
17,181 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-1324-2014, exactly as published.

Show all FDA fields
City
North Wales
State
PA
Status
Terminated
Country
United States
Event ID
68069
Address
1090 Horsham Rd
Code information
Lot #: 34013132A, 34013133A, 34013134A, 34013135A, 34013136A, Exp 11/14
Postal code
19454-1505
Report date
May 28, 2014
Product type
Drugs
Recall number
D-1324-2014
Classification
Class II
Recalling firm
Teva Pharmaceuticals USA
Product quantity
17,181 bottles
Termination date
Nov 20, 2014
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Voluntary / mandated
Voluntary: Firm initiated
Product description
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Apr 7, 2014
Initial firm notification
Letter
Center classification date
May 16, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1324-2014, published May 28, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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