Teva Recalls Buprenorphine Hydrochloride Sublingual Tablets Due to Impurity Failures
Teva Pharmaceuticals is recalling 17,181 bottles of 2 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant potential health risks, even without reported injuries.
Plain-English summary
Teva Pharmaceuticals USA is recalling 17,181 bottles of Buprenorphine Hydrochloride Sublingual Tablets, 2 mg, 30-count bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico. The affected lots are 34013132A, 34013133A, 34013134A, 34013135A, and 34013136A, all with an expiration date of 11/14.
The recall was initiated because high out-of-specification impurity test results were obtained during stability testing. This indicates that the product failed to meet the required impurities and degradation specifications.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- 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.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,181
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 (6)
- Lot #: 34013132A
- 34013133A
- 34013134A
- 34013135A
- 34013136A
- Exp 11/14
Distribution
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.
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