Med Pride triple antibiotic ointment packets recalled over manufacturing deviations
Med Pride Triple Antibiotic Ointment in 0.9 g packets is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 3,006 tubes affected.
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: FDA Class II recall arising from inspection-observed manufacturing deviations with no product defect or consequence described, which fits the Moderate band.
Plain-English summary
Med Pride Triple Antibiotic Ointment, containing bacitracin zinc (equivalent to 400 units), neomycin sulfate 5 mg and polymyxin B 5,000 units, in 0.9 g packets, 144 packets per 130 g box, manufactured for Shield Line LLC of Bayonne, New Jersey, is being recalled. The action covers 3,006 tubes.
The stated reason is CGMP deviations and deficiencies observed during an FDA inspection. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected lots are 011, 014, 015, 016, 017, 018, 019, 020, 021, 022 and 026, within expiry. Distribution was USA nationwide.
Consumers who have an affected lot should stop using it and follow the instructions issued by the firm.
The recalled product
- Product
- Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1.
- Manufacturer
- Dabur India Limited
- Affected units
- 3,006
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# 011
- 014
- 015
- 016
- 017
- 018
- 019
- 020
- 021
- 022
- 026
- Within Expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Dabur India 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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