Reported Aug 5, 2020 · Terminated
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only
- Mfg bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
- Lot codes and dates
Lot #: AA84106Exp 9/2021
- Amount recalled
- 3516 bottles
Where it was sold
- Nationwide
Why it was recalled
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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