FDA Drug Recalls

Recalls / Class II

Class IID-0072-2023

Product

Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01

Brand name
Desmopressin Acetate
Generic name
Desmopressin Acetate
Active ingredient
Desmopressin Acetate
Route
Oral
NDCs
23155-489, 23155-490
FDA application
ANDA207880
Affected lot / code info
Lot #: 220440A, Exp. Date 05/2024

Why it was recalled

Subpotent Drug

Recalling firm

Firm
Heritage Pharmaceuticals Inc
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Tower Center Blvd Ste 1700, East Brunswick, New Jersey 08816-1145

Distribution

Quantity
13805 Bottles each containing 100 tablets
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2022-11-23
FDA classified
2022-11-29
Posted by FDA
2022-12-07
Terminated
2023-12-13
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0072-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.