Drug product
Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
D-1526-2019
Product summary
- Firm
- Geritrex, LLC
- Event
- Event 83200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6213 bottles
- Official record key
drug-enforcement:D-1526-2019
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