Actavis Recalls Vancomycin Hydrochloride Capsules Due to Subpotent Drug
Actavis Inc. is voluntarily recalling 29,405 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug was found to be subpotent.
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 FDA classified this recall as Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm or hospitalization reports are rated as Severe (4).
Plain-English summary
Actavis Inc. is voluntarily recalling 29,405 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack. The product is manufactured for Watson Pharma Inc. by Patheon Pharmaceuticals Inc. The recall was initiated on February 12, 2015, and the FDA classified it as Class II.
The reason for the recall is that the drug was found to be subpotent, meaning it may not contain the full amount of the active ingredient required by the USP standard. The affected lots are 3109554, 3111457, 3112973, 3114262, 3114076, 3115889, and 3116033, with expiration dates ranging from March 31, 2015, to December 31, 2015.
The product was distributed nationwide. Patients who have been prescribed this medication should consult their healthcare provider for guidance on alternative treatment options. The recall was terminated on December 4, 2015.
The recalled product
- Product
- Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
- Manufacturer
- Actavis Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 29,405
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 (12)
- Lot #: 3109554
- Exp 3/31/2015
- Lot #: 3111457
- Lot #: 3112973
- Exp 7/31/2015
- Lot #: 3114262
- Exp 6/30/2015
- Lot #: 3114076
- Exp 12/31/2015
- Lot #: 3115889
- Lot #: 3116033
- Exp 12/31/2015.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Actavis Inc 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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