Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide
Actavis Inc is recalling 6,913 packages of Vancomycin Hydrochloride Capsules because the drug is subpotent. The recall covers distribution across the United States.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of the specific hazard type.
Plain-English summary
Actavis Inc has voluntarily recalled 6,913 packages of Vancomycin Hydrochloride Capsules, USP, 250 mg. The affected product is packaged as 20 capsules on 2 x 10 capsule blister cards and is marked for prescription use only. The specific lot number is 3100135, with an expiration date of 05/2014.
The recall was initiated because the drug is subpotent, meaning it does not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP). The product was manufactured by Patheon Pharmaceuticals Inc. for Watson Pharma Inc. and distributed nationwide in the United States.
The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Consumers and healthcare providers should stop using the affected lot and return it to the pharmacy or contact their healthcare provider for a replacement.
The recalled product
- Product
- Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.
- Manufacturer
- Actavis Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 6,913
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 #: 3100135
- Expiry: 05/2014
Distribution
Distributed nationwide across the United States.
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