Recalls / Class II
Class IID-0831-2020
Product
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
- Affected lot / code info
- Lot #: 1269726M, exp. date 01/2020; 1283269M, 1283270M, exp. date 03/2020; 1292992M,1292993A, exp. date 04/2020
Why it was recalled
GMP Deviations: Product bottle may be absent of desiccant.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 69,012 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-01-27
- FDA classified
- 2020-02-06
- Posted by FDA
- 2020-02-12
- Terminated
- 2020-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0831-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.