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Class II: temporary or reversible health riskTerminated

Glenmark Pharmaceuticals Desmopressin Acetate Tablets Recall

Desmopressin Acetate Tablets, 0

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Risk level
Class II
Reported by FDA
Jul 6, 2022
Recall ID
D-1171-2022
Check your lot numberHow we source this data

Summary

Glenmark Pharmaceuticals recalled Desmopressin Acetate Tablets starting Jun 29, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1171-2022 on Jul 6, 2022. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01

Lot numbers, UPCs & expiration codes

Lot #: 20020121, Exp 01/2024

Where it was sold

One sole distributor in TX

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-1171-2022
Classification
Class II
Status
Terminated
Recall initiated
Jun 29, 2022
FDA report date
Jul 6, 2022
Quantity
36 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Glenmark Pharmaceuticals Inc., USA

Original FDA data

Every field from FDA enforcement report D-1171-2022, exactly as published.

Show all FDA fields
City
Mahwah
State
NJ
Status
Terminated
Country
United States
Event ID
90431
Address
750 Corporate Dr
Code information
Lot #: 20020121, Exp 01/2024
Postal code
07430-2009
Report date
Jul 6, 2022
Product type
Drugs
Recall number
D-1171-2022
Classification
Class II
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product quantity
36 bottles
Termination date
Jun 23, 2023
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
Distribution pattern
One sole distributor in TX
Recall initiation date
Jun 29, 2022
Initial firm notification
Letter
Center classification date
Jun 30, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1171-2022, published Jul 6, 2022. 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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