FDA Drug Recalls

Recalls / Class II

Class IID-1526-2019

Product

Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16

Affected lot / code info
Lot #: 70602, Exp 6/19

Why it was recalled

cGMP Deviations: Products may have microbial contamination.

Recalling firm

Firm
Geritrex, LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
40 Commercial Ave, N/A, Middletown, New York 10941-1444

Distribution

Quantity
6213 bottles
Distribution pattern
U.S.A. Nationwide

Timeline

Recall initiated
2019-05-31
FDA classified
2019-07-25
Posted by FDA
2019-07-31
Terminated
2024-02-02
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1526-2019. 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