The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0847-2018·Announced 2018-06-20

RIJ Pharmaceutical Recalls Acetaminophen Elixir Due to Microbial Count

RIJ Pharmaceutical is recalling 228 bottles of RPC APAP 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 a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported illness.

Plain-English summary

RIJ Pharmaceutical LLC is recalling 228 bottles of RPC APAP Elixir (Acetaminophen 160mg) packaged in 16 FL. OZ. (473 mL) bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically an out-of-specification total aerobic microbial count detected in a water sample.

The affected product is identified by Lot # 47080092 with an expiration date of 08/19. The product was distributed nationwide in the USA. The FDA has classified this recall as Class II.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
Manufacturer
RIJ Pharmaceutical LLC
Category
Drug — Liquid Oral
Hazard
Affected units
228

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 #: 47080092
  • 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 →

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