Glenmark Recalls Clotrimazole and Betamethasone Cream Due to Temperature Abuse
Glenmark Pharmaceuticals is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream due to complaints of a liquidy texture caused by temperature abuse.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for cosmetic or packaging-only issues.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes. The product is a prescription-only topical cream manufactured in India for Glenmark Pharmaceuticals Inc. in the United States. The specific lot number is 05180734 with an expiration date of 03/2020.
The recall was initiated due to complaints regarding a liquidy texture in the product, which the source attributes to temperature abuse. The agency has classified this as a Class III recall, indicating that the product is not likely to cause adverse health consequences.
The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE)
- Brand
- CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical Cream
- Affected units
- 31,224
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 #: 05180734
- Exp. 03/2020
UPCs (2)
- 0368462298176
- 0368462298558
Distribution
Distributed nationwide across the United States.
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