RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Contamination
RIJ Pharmaceutical LLC is recalling RPC 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 and involves a low-risk contamination (microbial count in water) without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
RIJ Pharmaceutical LLC is recalling 1,505 bottles of RPC Senna Syrup (Sennosides 8.8mg) in 8 fl oz (237 mL) bottles. The product is identified by NDC 5380755608, UPC 353807556080, Lot # 47070081, and an expiration date of 09/18.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically an out-of-specification total aerobic microbial count detected in a water sample. The product was distributed nationwide in the USA.
Consumers should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
- Manufacturer
- RIJ Pharmaceutical LLC
- Category
- Drug — Liquid Oral
- Hazard
- Affected units
- 1,505
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 (2)
- Lot #: 47070081
- 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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