Dr. Reddy's Recalls Clocortolone Pivalate Cream Due to Stability Issues
Dr. Reddy's Laboratories is recalling Clocortolone Pivalate Cream, 0.1%, 90-gram tubes because viscosity failed stability specifications.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a stability specification failure without reported injuries.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Clocortolone Pivalate Cream, 0.1%, 90-gram tubes (NDC 43598-341-90). The recall involves 4,152 tubes from Lot # MGEC, which were distributed nationwide in the USA.
The recall was initiated due to out-of-specification results observed for viscosity during stability testing. This indicates that the product did not meet the required stability specifications.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 4,152
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 (1)
- Lot # MGEC
Distribution
Distributed nationwide across the United States.
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