Hikma Recalls Buprenorphine Hydrochloride Injection Due to Low Potency
Hikma Pharmaceuticals is recalling 97,890 vials of Buprenorphine Hydrochloride Injection because stability testing revealed the drug was sub-potent.
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. The hazard is sub-potency (low potency), which is a quality issue that may result in therapeutic failure but does not involve immediate physical injury or contamination, fitting the Moderate severity criteria for minor labeling or quality errors without reported harm.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling 97,890 vials of Buprenorphine Hydrochloride Injection, 0.3 mg/mL, 1 mL vial. The product is intended for intramuscular or intravenous use only and is distributed nationwide in the U.S.
The recall was initiated because out-of-specification assay results were found during 3-month stability testing, indicating the drug was sub-potent. The affected lots are 2005023.1, 2005024.1, and 2005025.1, all with an expiration date of 02/28/2021.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. Patients and providers should verify lot numbers against the recall list and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 97,890
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 (4)
- Lot #s: 2005023.1
- 2005024.1
- 2005025.1
- Exp 02/28/2021
Distribution
Distributed nationwide across the United States.
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