Agency classClass IIOur severity:Severe FDA (Drugs)·D-0233-2015·Announced 2014-11-05

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.

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 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: subpotent-drug
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.

See all 2 products in this recall →

Same manufacturer · Actavis Inc

See all →

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Same hazard · subpotent drug