The Recall Desk
ModerateFDA (Drugs)·D-0067-2019·Announced 2018-10-24

Rite Aid First Aid Antibiotic Ointment Recalled for Low Bacitracin Zinc

Product Quest Manufacturing LLC is recalling Rite Aid First Aid Antibiotic Ointment because the bacitracin zinc ingredient was found to be subpotent.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported hospitalizations or injuries, as the hazard is a subpotent drug rather than a direct physical injury risk.

Plain-English summary

Product Quest Manufacturing LLC is recalling 5,004 tubes of Rite Aid Pharmacy, First Aid Antibiotic Ointment. The product is a 2 OZ (56 g) tube containing neomycin sulfate, polymyxin B sulfate, and bacitracin zinc. The specific lot affected is 170591E, with an expiration date of 11/17/18. The product was distributed nationwide in the USA by Rite Aid.

The recall was initiated because the product is a subpotent drug. Specifically, the assay results for the bacitracin zinc ingredient were found to be low and out of specification. This means the product may not contain the full amount of the active ingredient required to be effective.

Consumers who have this product should stop using it and return it to the place of purchase for a refund. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
Affected units
5,004

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 (2)

  • Lot: 170591E
  • Exp. 11/17/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 54 recalled by Product Quest Manufacturing LLC 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 54 products in this recall →