Drug product
Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16
D-1522-2019
Product summary
- Firm
- Geritrex, LLC
- Event
- Event 83200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6165 bottles
- Official record key
drug-enforcement:D-1522-2019
Official wording
Reason: cGMP Deviations: Products may have microbial contamination.
Code information: Lot #: 70612, Exp 6/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Microbial contamination
microbial contamination