Class III
Terminated
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
This recall has been terminated (originally issued July 12, 2017).
- Company
- Sandoz Incorporated
- Recall Initiated
- June 16, 2017
- Posted
- July 12, 2017
- Recall Number
- D-0943-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 38,234 bottles
- Firm Location
- Broomfield, CO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Cross Contamination With Other Product: Imipramine
Distribution
Product was distributed throughout the United States
Lot / Code Info
Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
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