Recalls / Class II
Class IID-1527-2019
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
- Affected lot / code info
- Lot #: 70603, 70604, 70612, Exp 6/19
Why it was recalled
cGMP Deviations: Products may have microbial contamination.
Recalling firm
- Firm
- Geritrex, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 40 Commercial Ave, N/A, Middletown, New York 10941-1444
Distribution
- Quantity
- 15435 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-05-31
- FDA classified
- 2019-07-25
- Posted by FDA
- 2019-07-31
- Terminated
- 2024-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1527-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.