FDAFDA · Food and drugs·Recall number D-0943-2017
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
Published July 12, 2017 · Recall initiated: June 16, 2017
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 Product: Imipramine
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMITRIPTYLINE HYDROCHLORIDE
- Manufacturer
- Sandoz Incorporated
- Distributor
- Product was distributed throughout the United States
- Lot
- Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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