Recalls / Class II
Class IID-0848-2020
Product
Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11
- Affected lot / code info
- Lot 181109, exp 4/30/2020
Why it was recalled
GMP Deviations: Product bottle may be absent of desiccant.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 1,879 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2020-02-07
- FDA classified
- 2020-02-18
- Posted by FDA
- 2020-02-26
- Terminated
- 2022-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0848-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.