Med Pride hydrocortisone cream 1oz tubes recalled over manufacturing deviations
Med Pride Hydrocortisone Cream 1%, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,944 tubes are 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 Hydrocortisone Cream 1%, net weight 1 oz (28.3 g) tubes, manufactured for Shield Line LLC of Bayonne, New Jersey and made in India, UPC 3 52410 30503 0, is being recalled. The action covers 4,944 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 001, 002, 013, 016, 031, 032, 033, 045, 046 and 047, 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, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
- Manufacturer
- Dabur India Limited
- Affected units
- 4,944
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 (11)
- Lot# 001
- 002
- 013
- 016
- 031
- 032
- 033
- 045
- 046
- 047
- 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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