The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0233-2017·Announced 2017-01-04

Raritan Recalls Kids' Relief Ear Liquid Due to Manufacturing Deviations

Raritan Pharmaceuticals is recalling 22,704 bottles of Kids' Relief Ear Relief Oral Liquid in New York due to CGMP deviations.

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 is voluntary due to CGMP deviations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/manufacturing errors without reported injuries.

Plain-English summary

Raritan Pharmaceuticals, Inc. is voluntarily recalling 22,704 bottles of Kids' Relief Ear Relief Oral Liquid, 0.85 fl oz. (25 mL). The affected product is identified by Lot # 35254 and an expiration date of 05/20. The recall was initiated on November 18, 2016, and was classified as Class II by the FDA.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in New York. The recall status is currently terminated as of January 8, 2020.

Consumers who have this product should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639
Manufacturer
Raritan Pharmaceuticals, Inc.
Category
Drug — Ophthalmic/Ear
Hazard
Affected units
22,704

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 # 35254
  • Exp. 05/20

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Raritan Pharmaceuticals, Inc. 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 3 products in this recall →

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