RIJ Pharmaceutical Recalls Children's Acetaminophen Elixir Due to Microbial Count
RIJ Pharmaceutical LLC is recalling 1,272 bottles of RPC Children's Non-Aspirin Elixir 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 moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.
Plain-English summary
RIJ Pharmaceutical LLC is recalling 1,272 bottles of RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, 4 FL. OZ. (118 mL). The product is identified by NDC 53807-129-04, UPC 353807129048, Lot # 47080091, and an expiration date of 08/19.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the company identified an out-of-specification total aerobic microbial count in a water sample used during the manufacturing process.
The affected product was distributed nationwide in the USA. Consumers should check their medicine cabinets for this specific product and lot number. If found, they should stop using the product and contact their pharmacist or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048
- Manufacturer
- RIJ Pharmaceutical LLC
- Category
- Drug — Liquid OTC
- Hazard
- Affected units
- 1,272
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 #: 47080091
- 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.
See all 12 products in this recall →Related recalls
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