Recalls / Class II
Class IID-0077-2023
Product
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
- Affected lot / code info
- Lot # B1817019-082222, Exp. 02/24/2023; B1819127-082322, Exp. 02/26/2023
Why it was recalled
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 9 boxes
- Distribution pattern
- Product was distributed to two different customers in MI.
Timeline
- Recall initiated
- 2022-12-05
- FDA classified
- 2022-12-07
- Posted by FDA
- 2022-12-14
- Terminated
- 2023-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0077-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.