Recalls / Class II
Class IID-1436-2019
Product
Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
- Affected lot / code info
- Lot #: 1804012, Exp. 08/2019
Why it was recalled
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
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
- 1536 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-05-06
- FDA classified
- 2019-06-28
- Posted by FDA
- 2019-06-19
- Terminated
- 2024-02-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1436-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.