Sun Pharmaceutical Recalls Clonazepam Tablets Due to Cross-Contamination
Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets because routine stability testing detected cross-contamination with clozapine.
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: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. Given the presence of a cross-contamination hazard (clozapine) rather than a purely cosmetic or documentation issue, a score of 2 (Moderate) is appropriate.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 3,516 bottles of Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg. The affected product is identified by Lot # AA84106 and has an expiration date of 9/2021. The recall is being conducted because routine stability testing discovered an out-of-specification (OOS) result for the highest unknown impurity, which was later identified as clozapine.
The recall covers products distributed nationwide in the United States. The source text does not specify specific states or distribution channels beyond the nationwide scope. No illnesses or injuries are reported in the source text.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
- Affected units
- 3,516
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 #: AA84106
- Exp 9/2021
Distribution
Distributed nationwide across the United States.
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