Teva Recalls Buprenorphine and Naloxone Sublingual Tablets Due to Impurities
Teva Pharmaceuticals is recalling specific lots of Buprenorphine and Naloxone Sublingual Tablets because they failed impurity and degradation specifications.
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' severity score under the rubric for significant injury or property-damage reports or high-risk scenarios without confirmed fatalities.
Plain-English summary
Teva Pharmaceuticals USA is recalling 7,628 bottles of Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg. The recall involves Lot 30227056A with an expiration date of 03/17. The product is distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Sublingual Tablets
- Hazard
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 (2)
- Lot 30227056A
- Exp. 03/17
Distribution
Distributed nationwide across the United States.
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