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