FDA Drug Recalls

Recalls / Class II

Class IID-1322-2022

Product

A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.

Why it was recalled

CGMP Deviations: products were stored outside the drug label specifications.

Recalling firm

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233

Distribution

Quantity
1 Jar
Distribution pattern
Nationwide in the USA.

Timeline

Recall initiated
2022-06-29
FDA classified
2022-08-05
Posted by FDA
2022-08-17
Terminated
2024-02-13
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1322-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls