D-1527-2019 Class II Terminated
FDA drug recall D-1527-2019 was initiated by Geritrex, LLC on May 31, 2019 and is designated Class II. Reason for recall: cGMP Deviations: Products may have microbial contamination. The recall status is terminated (terminated February 2, 2024). Affected quantity: 15435 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- May 31, 2019
- Termination Date
- February 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15435 bottles
Product Description
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
Reason for Recall
cGMP Deviations: Products may have microbial contamination.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 70603, 70604, 70612, Exp 6/19