PlainRecalls
FDA Drug Moderate Class II Terminated

SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082

Reported: June 20, 2018 Initiated: May 7, 2018 #D-0851-2018

Product Description

SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082

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
3537 bottles
Distribution
Nationwide in the USA
Location
Middletown, NY

Frequently Asked Questions

What product was recalled?
SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082. Recalled by RIJ Pharmaceutical LLC. Units affected: 3537 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-0851-2018.