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Class II · Moderate risk Terminated Initiated Nov 18, 2016 (10 years ago)

CVS Health Homeopathic Infants Teething Tablets 135 count bottle…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

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

Affected NDC 59779-0860-03

Compare with the code on your package — it is the most precise check available.

Recalling firm
Raritan Pharmaceuticals, Inc.
NDC code
59779-860-03
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0232-2017 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Raritan Pharmaceuticals, Inc.

All 2016 recalls
Class II · Moderate risk

DRxChoice Fiber Capsules

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. D-032-2013

Other cgmp deviation recalls from 2016

All cgmp deviation recalls