Rapidol Triple Antibiotic Ointment Recalled for CGMP Deviations
Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.
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: This is an FDA Class II recall involving manufacturing deviations (CGMP) with no reported illnesses or injuries stated in the source text. Manufacturing defect concerns without evidence of harm typically fall into the Moderate range.
Plain-English summary
Kenil Healthcare Private Limited is recalling Rapidol Triple Antibiotic First Aid Ointment, 2 oz (56g) tubes, due to CGMP (Current Good Manufacturing Practice) deviations. The affected product is Lot SP27A with expiration date 09/30/2026, NDC 55758-440-02, distributed by Pharmadel LLC in Delaware and North Carolina.
A total of 9,336 tubes have been distributed. This is a voluntary, firm-initiated recall classified as Class II by the FDA. Consumers who have purchased this product should discontinue use and contact their healthcare provider if they have any questions or concerns about the medication's safety or efficacy.
The recalled product
- Product
- RAPIDOL (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
- Brand
- RAPIDOL
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Affected units
- 9,336
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 SP27A
- Exp: 09/30/2026
UPCs (1)
- 810096771629
Distribution
Part of a larger recall action
This product is one of 20 recalled by KENIL HEALTHCARE PRIVATE LIMITED 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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