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
- Manufacturer
- RIJ Pharmaceutical LLC
- Category
- Drug — Liquid Oral
- Hazard
- 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.
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