Drug product
Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
D-1521-2019
Product summary
- Firm
- Geritrex, LLC
- Event
- Event 83200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5107 bottles
- Official record key
drug-enforcement:D-1521-2019
Official wording
Reason: cGMP Deviations: Products may have microbial contamination.
Code information: Lot #: 70602, Exp 6/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Microbial contamination
microbial contamination