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Class III: unlikely to cause harmTerminated

Sandoz Amitriptyline HCl Tablets Recall

Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01…

Sandoz Incorporated · Broomfield, CO

Risk level
Class III
Reported by FDA
Jul 12, 2017
Recall ID
D-0943-2017
Check your lot numberHow we source this data

Summary

Sandoz recalled Amitriptyline HCl Tablets starting Jun 16, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0943-2017 on Jul 12, 2017. Reason: Cross Contamination With Other Product: Imipramine. Status: Terminated.

Why it was recalled

Cross Contamination With Other Product: Imipramine

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

Lot numbers, UPCs & expiration codes

Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.

Where it was sold

Product was distributed throughout the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0943-2017
Classification
Class III
Status
Terminated
Recall initiated
Jun 16, 2017
FDA report date
Jul 12, 2017
Quantity
38,234 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Sandoz Incorporated

Original FDA data

Every field from FDA enforcement report D-0943-2017, exactly as published.

Show all FDA fields
City
Broomfield
State
CO
Status
Terminated
Country
United States
Event ID
77567
Address
2555 W Midway Blvd
Code information
Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
Postal code
80020-1632
Report date
Jul 12, 2017
Product type
Drugs
Recall number
D-0943-2017
Classification
Class III
Recalling firm
Sandoz Incorporated
Product quantity
38,234 bottles
Termination date
Jan 14, 2019
Reason for recall
Cross Contamination With Other Product: Imipramine
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Product was distributed throughout the United States
Recall initiation date
Jun 16, 2017
Initial firm notification
Letter
Center classification date
Jul 6, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0943-2017, published Jul 12, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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