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
Reported: July 12, 2017 Initiated: June 16, 2017 #D-0943-2017
Product Description
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
Reason for Recall
Cross Contamination With Other Product: Imipramine
Details
- Recalling Firm
- Sandoz Incorporated
- Units Affected
- 38,234 bottles
- Distribution
- Product was distributed throughout the United States
- Location
- Broomfield, CO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Incorporated. Units affected: 38,234 bottles.
Why was this product recalled? ▼
Cross Contamination With Other Product: Imipramine
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 12, 2017. Severity: Low. Recall number: D-0943-2017.
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