FDA Drug Recalls

Recalls / Class III

Class IIID-1235-2015

Product

Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.

Affected lot / code info
Lot #:151360, Expiry: 12/31/2016

Why it was recalled

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Recalling firm

Firm
American Health Packaging
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188

Distribution

Quantity
341 Cartons
Distribution pattern
U.S. Nationwide

Timeline

Recall initiated
2015-06-26
FDA classified
2015-07-14
Posted by FDA
2015-07-22
Terminated
2018-08-15
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1235-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.