Recalls / Class III
Class IIID-1285-2015
Product
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.
- Affected lot / code info
- Lot # 982021M, Expiry: DEC. 2016
Why it was recalled
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Recalling firm
- Firm
- Actavis Laboratories, FL, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 4955 Orange Dr, N/A, Davie, Florida 33314-3902
Distribution
- Quantity
- 11,445 Bottles
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2015-06-23
- FDA classified
- 2015-08-04
- Posted by FDA
- 2015-08-12
- Terminated
- 2016-12-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1285-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.