RIJ Pharmaceutical Recalls Ritussin DM Due to Microbial Count Deviation
RIJ Pharmaceutical is recalling 9,240 bottles of Ritussin DM because a water sample showed an out-of-specification total aerobic microbial count.
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, which typically involves a low probability of serious adverse health consequences. The hazard is a CGMP deviation involving microbial count in a water sample, which is a low-risk contamination issue without reported illnesses.
Plain-English summary
RIJ Pharmaceutical LLC is recalling 9,240 bottles of Ritussin DM Dextromethorphan Hydrobromide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL) bottles. The product is identified by NDC 5380740904, UPC 35380740941, Lot # 47070021, and an expiration date of 07/19. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations.
The recall was initiated because a water sample used in the manufacturing process resulted in an out-of-specification total aerobic microbial count. This indicates a deviation from quality standards regarding microbial contamination in the production environment.
The affected product was distributed nationwide in the USA. Consumers who have this specific lot of Ritussin DM should stop using it and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
- Manufacturer
- RIJ Pharmaceutical LLC
- Category
- Drug — Cough and Cold Medication
- Affected units
- 9,240
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 #: 47070021
- Exp. 07/19
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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