FDAClass IIJune 20, 2018

SDA Senna Syrup recall: CGMP Deviations

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

Why was SDA Senna Syrup recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 47070042, Exp. 09/18

Product
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
Recalling firm
RIJ Pharmaceutical LLC
Quantity
3537 bottles
Distribution
Nationwide in the USA
Recall date
June 20, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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