Reported Jul 12, 2017 · Terminated
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles (…
Sandoz Incorporated
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: Sandoz Incorporated · 2555 W Midway Blvd · Broomfield, CO · 80020-1632
Is this the product you have?
- Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
- Lot codes and dates
Lot #: a) GR3831GS9690Exp. 08/2019b) GR3832Exp. 08/2019
- Amount recalled
- 38,234 bottles
Why it was recalled
Cross Contamination With Other Product: Imipramine
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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