The Recall Desk
ModerateFDA (Drugs)·D-0234-2017·Announced 2017-01-04

Raritan Recalls CVS Kids' Ear Relief Liquid for Manufacturing Deviations

Raritan Pharmaceuticals is voluntarily recalling 20,448 bottles of CVS pharmacy Kids' Ear Relief Oral Liquid due to Current Good Manufacturing Practice (CGMP) deviations.

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 due to CGMP deviations, which typically corresponds to a moderate risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Raritan Pharmaceuticals, Inc. is voluntarily recalling 20,448 bottles of CVS pharmacy Kids' Ear Relief Oral Liquid, 0.85 oz (25 mL). The product is distributed by CVS Pharmacy, Inc. and carries the NDC 59779-687-02 and UPC 77815909639. The specific lot affected is # 33149 with an expiration date of 01/20.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed in New York. Consumers who have this product should stop using it and contact CVS Pharmacy or Raritan Pharmaceuticals for further instructions or a refund.

The recalled product

Product
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639
Affected units
20,448

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 # 33149
  • Exp. 01/20

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 →

Same hazard · cgmp deviations

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