Drug product
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
D-0943-2017
Product summary
- Event
- Event 77567
- Status
- Terminated
- Classification
- Class III
- Quantity
- 38,234 bottles
- Official record key
drug-enforcement:D-0943-2017
Official wording
Reason: Cross Contamination With Other Product: Imipramine
Code information: Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Unknown
Cross Contamination With Other Product: Imipramine