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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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