Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide
Actavis Inc. is voluntarily recalling 46,676 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug is subpotent.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no specific injuries are listed, the rubric mandates a minimum score of 4 for FDA Class II classifications when significant harm potential is implied by the 'subpotent' nature of a critical antibiotic, aligning with the 'Severe' criteria for significant injury reports or structural defects in critical medical contexts.
Plain-English summary
Actavis Inc. is voluntarily recalling 46,676 cartons of Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister packs. The recall was initiated on August 25, 2014, and is classified as Class II by the FDA. The product is manufactured for Watson Pharma. Inc. and by Patheon Pharmaceuticals Inc.
The reason for the recall is that the drug is subpotent, meaning it does not contain the full amount of the active ingredient required by the USP. The affected lots have expiration dates ranging from August 2014 to December 2014. The specific lot codes are 3101178, 3104318, 3104319, 3104889, 3104891, 3104893, and 3106651.
The product was distributed nationwide. The recall was initiated by the firm and is voluntary. The recall status is currently terminated as of March 21, 2018. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates.
The recalled product
- Product
- Vancomycin Hydrochloride Capsule, USP, 250 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 0591-3561-15 UPC 3-3-0591356115-1
- Manufacturer
- Actavis Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 46,676
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 (11)
- 3101178
- exp Aug 2014
- 3104318
- 3104319
- exp Oct 2014
- 3104889
- exp Oct 2014
- 3104891
- 3104893
- and 3106651
- exp Dec 2014
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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