FDA Drug Recalls

Recalls / Class II

Class IID-1525-2019

Product

Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941

Affected lot / code info
Lot #: 70611, 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
7653 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-1525-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.