Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide
Actavis Inc is voluntarily recalling 26,663 cartons of Vancomycin Hydrochloride Capsules because the drug was found to be subpotent.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a subpotent drug, which poses a risk of treatment failure without reported injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Actavis Inc is voluntarily recalling 26,663 cartons of Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister packs. The recall was initiated because the product was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP).
The affected product is manufactured for Watson Pharma. Inc. in Parsippany, NJ, and manufactured by Patheon Pharmaceuticals Inc. in Cincinnati, OH. The recall covers four specific lot numbers with expiration dates ranging from August 2014 to December 2014. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for a replacement. The recall was initiated by the firm and has since been terminated.
The recalled product
- Product
- Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4
- Manufacturer
- Actavis Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 26,663
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 (7)
- 3103681
- exp Aug 2014
- 3104886
- exp Oct 2014
- 3105836
- exp Dec 2014
- and 3106650
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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