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
Reported: August 5, 2020 Initiated: July 6, 2020 #D-1445-2020
Product Description
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
Reason for Recall
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 3516 bottles
- Distribution
- Nationwide USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 3516 bottles.
Why was this product recalled? ▼
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 5, 2020. Severity: Low. Recall number: D-1445-2020.
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