RIJ Pharmaceutical Recalls Gericare Acetaminophen Due to Microbial Count
RIJ Pharmaceutical LLC is recalling Gericare Liquid Pain Relief Acetaminophen 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 CGMP deviation regarding microbial counts in a water sample, which fits the criteria for a moderate severity voluntary precautionary recall without reported illnesses.
Plain-English summary
RIJ Pharmaceutical LLC is recalling Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL) bottles. The recall involves 13,380 bottles distributed nationwide in the USA. The specific lots affected are 47080081 and 47080093, with an expiration date of 08/19.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product is being recalled because of an out-of-specification total aerobic microbial count detected in a water sample.
Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess these products, they should stop using them and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164
- Manufacturer
- RIJ Pharmaceutical LLC
- Category
- Drug — Liquid Analgesic
- Affected units
- 13,380
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 (3)
- Lot #: 47080081
- 47080093
- Exp. 08/19
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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