Dr. Reddy's Quetiapine Fumarate Tablets Recalled for Dissolution Failure
Dr. Reddy's is recalling Quetiapine Fumarate Tablets, 25mg, because they failed USP dissolution testing during stability studies.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets (NDC 55111-249-05). The recall involves 1,512 bottles of Lot C203090 with an expiration date of 03/14. The product was distributed nationwide with no foreign consignees.
The recall was initiated because the product failed USP Dissolution Test Requirements. During the analysis of long-term stability studies at the 3-month time point, an out-of-specification (OOS) result was reported for the Quetiapine Fumarate Tablets, 25 mg.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Dr. Reddy's Laboratories for further instructions or a replacement.
The recalled product
- Product
- Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,512
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 C203090 Exp.03/14
Distribution
Distributed nationwide across the United States.
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