Drug product
Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16
D-1527-2019
Product summary
- Firm
- Geritrex, LLC
- Event
- Event 83200
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15435 bottles
- Official record key
drug-enforcement:D-1527-2019
Official wording
Reason: cGMP Deviations: Products may have microbial contamination.
Code information: Lot #: 70603, 70604, 70612, Exp 6/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Microbial contamination
microbial contamination