Recalls / Class III
Class IIID-0943-2017
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
- Brand name
- Amitriptyline Hydrochloride
- Generic name
- Amitriptyline Hydrochloride
- Active ingredient
- Amitriptyline Hydrochloride
- Route
- Oral
- NDCs
- 0781-1486, 0781-1487, 0781-1488, 0781-1489, 0781-1490, 0781-1491
- FDA application
- ANDA085968
- Affected lot / code info
- Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
Why it was recalled
Cross Contamination With Other Product: Imipramine
Recalling firm
- Firm
- Sandoz Incorporated
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 38,234 bottles
- Distribution pattern
- Product was distributed throughout the United States
Timeline
- Recall initiated
- 2017-06-16
- FDA classified
- 2017-07-06
- Posted by FDA
- 2017-07-12
- Terminated
- 2019-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0943-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.