The Recall Desk
ModerateFDA (Drugs)·D-0848-2018·Announced 2018-06-20

GeriCare Senna Syrup Recalled for Microbial Contamination

RIJ Pharmaceutical LLC is recalling GeriCare Senna Syrup due to out-of-specification microbial counts in a water sample.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations and microbial contamination in a water sample, but no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

RIJ Pharmaceutical LLC is recalling 21,213 bottles of GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL). The product was distributed nationwide in the USA. The recall involves specific lots with expiration dates of 09/18.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification total aerobic microbial count was detected in a water sample. The agency has classified this as a Class II recall.

Consumers who have this product should stop using it and contact the recalling firm for instructions on disposal or return.

The recalled product

Product
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
Affected units
21,213

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 47070082
  • 47070043
  • 47070011
  • Exp. 09/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by RIJ Pharmaceutical LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →