The Recall Desk
ModerateFDA (Drugs)·D-1325-2014·Announced 2014-05-28

Teva Recalls Buprenorphine Hydrochloride Tablets Due to Impurity Test Failures

Teva Pharmaceuticals is recalling 53,452 bottles of 8 mg Buprenorphine Hydrochloride sublingual tablets because stability testing revealed high out-of-specification impurity levels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity rating involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Teva Pharmaceuticals USA is recalling 53,452 bottles of Buprenorphine Hydrochloride Sublingual Tablets, 8 mg, 30-count bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico.

The recall was initiated because high out-of-specification impurity test results were obtained during stability testing. The affected lots include codes 34009367B, 34009368B, 34009369A, 34009370B (Exp 04/14); 34013141A, 34013142A (Exp 11/14); and 34016682A, 34016683A, 34016684A, 34017000A, 34017001A (Exp 08/15).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or supplier for disposal or replacement.

The recalled product

Product
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
53,452

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 34009367B
  • 34009368B
  • 34009369A
  • 34009370B
  • Exp 04/14
  • 34013141A
  • 34013142A
  • Exp 11/14
  • 34016682A
  • 34016683A
  • 34016684A
  • 34017000A
  • 34017001A
  • Exp 08/15

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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