Why it was recalled
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Product description
Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.
Lot numbers, UPCs & expiration codes
Lot # 982021M, Expiry: DEC. 2016
Where it was sold
U.S. Nationwide including Puerto Rico.
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-1285-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 23, 2015
- FDA report date
- Aug 12, 2015
- Quantity
- 11,445 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Laboratories, FL, Inc.
Original FDA data
Every field from FDA enforcement report D-1285-2015, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 71755
- Address
- 4955 Orange Dr
- Code information
- Lot # 982021M, Expiry: DEC. 2016
- Postal code
- 33314-3902
- Report date
- Aug 12, 2015
- Product type
- Drugs
- Recall number
- D-1285-2015
- Classification
- Class III
- Recalling firm
- Actavis Laboratories, FL, Inc.
- Product quantity
- 11,445 Bottles
- Termination date
- Dec 30, 2016
- Reason for recall
- Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Jun 23, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 4, 2015