The Recall Desk
SevereFDA (Drugs)·D-0406-2015·Announced 2015-03-11

Actavis Recalls Vancomycin Hydrochloride Capsules Due to Subpotent Drug

Actavis Inc. is voluntarily recalling 29,405 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug was found to be 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 FDA classified this recall as Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm or hospitalization reports are rated as Severe (4).

Plain-English summary

Actavis Inc. is voluntarily recalling 29,405 cartons of Vancomycin Hydrochloride Capsules, USP, 250 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 was found to be subpotent, meaning it may not contain the full amount of the active ingredient required by the USP standard. The affected lots are 3109554, 3111457, 3112973, 3114262, 3114076, 3115889, and 3116033, with expiration dates ranging from March 31, 2015, to December 31, 2015.

The product was distributed nationwide. Patients who have been prescribed this medication should consult their healthcare provider for guidance on alternative treatment options. The recall was terminated on December 4, 2015.

The recalled product

Product
Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
Manufacturer
Actavis Inc
Category
Drug — Antibiotic
Hazard
Affected units
29,405

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 (12)

  • Lot #: 3109554
  • Exp 3/31/2015
  • Lot #: 3111457
  • Lot #: 3112973
  • Exp 7/31/2015
  • Lot #: 3114262
  • Exp 6/30/2015
  • Lot #: 3114076
  • Exp 12/31/2015
  • Lot #: 3115889
  • Lot #: 3116033
  • Exp 12/31/2015.

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 →

Related recalls

Same manufacturer · Actavis Inc

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Same hazard · subpotent drug

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