Agency classClass IIOur severity:High FDA (Drugs)·D-0396-2015·Announced 2015-03-11

Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

Actavis Inc. is voluntarily recalling 51,472 cartons of Vancomycin Hydrochloride Capsules, USP, 125 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 3/5 (High).

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 is a subpotent drug, which poses a risk of treatment failure without reported injuries, 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 51,472 cartons of Vancomycin Hydrochloride Capsules, USP, 125 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 is subpotent, meaning it does not contain the full amount of the active ingredient required by the USP. The affected lots were distributed nationwide. The specific lot numbers and expiration dates are: 310935 (Exp 3/31/2015), 3109552 (Exp 3/31/2015), 3110204 (Exp 3/31/2015), 3112972 (Exp 7/31/2015), 3114073 (Exp 8/31/2015), 3115756 (Exp 10/31/2015), 3115888 (Exp 10/31/2015), and 3118059 (Exp 11/30/2015).

Patients who have received these specific lots of Vancomycin Hydrochloride Capsules should contact their healthcare provider for guidance. The recall was terminated on December 4, 2015.

The recalled product

Product: Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
Manufacturer: Actavis Inc
Category: Drug — Antibiotic
Hazard: subpotent-drug
Affected units: 51,472

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 (13)

Lot #: 310935 Exp 3/31/2015
Lot #: 3109552 Exp 3/31/2015
Lot #: 3110204
Exp 3/31/2015
Lot #: 3112972
Exp 7/31/2015
Lot #: 3114073
Exp 8/31/2015
Lot #: 3115756
Exp 10/31/2015
Lot #: 3115888
Lot #: 3118059
Exp 11/30/2015.

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.

See all 2 products in this recall →

Same manufacturer · Actavis Inc

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Same hazard · subpotent drug