Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0232-2017·Announced 2017-01-04

CVS Health Homeopathic Infants Teething Tablets Recalled for CGMP Deviations

Raritan Pharmaceuticals is voluntarily recalling CVS Health Homeopathic Infants Teething Tablets due to Current Good Manufacturing Practice (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 due to CGMP deviations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/process errors without reported serious injury.

Plain-English summary

Raritan Pharmaceuticals, Inc. is voluntarily recalling 45,648 bottles of CVS Health Homeopathic Infants Teething Tablets (135 count). The product is distributed by CVS Pharmacy, Inc. and carries NDC 59779-860-03 and UPC 0504284162. The recall was initiated on November 18, 2016, and the status is currently Terminated.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this recall as Class II, which indicates a situation in which there is a reasonable probability that the 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.

The affected lots are 41116 and 43436, with an expiration date of 03/20. The distribution pattern is listed as NY. Consumers should check their inventory for these specific lot numbers and expiration dates. The recall was initiated by the firm and notified via letter.

The recalled product

Product: CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162
Manufacturer: Raritan Pharmaceuticals, Inc.
Category: Drug — Homeopathic
Hazard: cgmp-deviation
Affected units: 45,648

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 #: 41116
43436
Exp. 03/20

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 manufacturer · Raritan Pharmaceuticals, Inc.

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Same hazard · cgmp deviation