PlainRecalls
FDA Drug Moderate Class II Terminated

GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087

Reported: June 20, 2018 Initiated: May 7, 2018 #D-0848-2018

Product Description

GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087

Reason for Recall

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Details

Recalling Firm
RIJ Pharmaceutical LLC
Units Affected
21213 bottles
Distribution
Nationwide in the USA
Location
Middletown, NY

Frequently Asked Questions

What product was recalled?
GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087. Recalled by RIJ Pharmaceutical LLC. Units affected: 21213 bottles.
Why was this product recalled?
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 20, 2018. Severity: Moderate. Recall number: D-0848-2018.