FDAFDA · Food and drugs·Recall number D-1445-2020
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
Published August 5, 2020 · Recall initiated: July 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide USA
- Lot
- Lot #: AA84106, Exp 9/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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