Agency classClass IIOur severity:Moderate FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: impurity
degradation
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 →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · impurity