Why it was recalled
GMP Deviations: Product bottle may be absent of desiccant.
Product description
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
Lot numbers, UPCs & expiration codes
Lot #: 1269726M, exp. date 01/2020; 1283269M, 1283270M, exp. date 03/2020; 1292992M,1292993A, exp. date 04/2020
Where it was sold
Nationwide within 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-0831-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 27, 2020
- FDA report date
- Feb 12, 2020
- Quantity
- 69,012 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0831-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84798
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 1269726M, exp. date 01/2020; 1283269M, 1283270M, exp. date 03/2020; 1292992M,1292993A, exp. date 04/2020
- Postal code
- 07054-1120
- Report date
- Feb 12, 2020
- Product type
- Drugs
- Recall number
- D-0831-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 69,012 bottles
- Termination date
- Dec 10, 2020
- Reason for recall
- GMP Deviations: Product bottle may be absent of desiccant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 27, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 6, 2020