← FDA ENFORCEMENT
D-0292-2024Class I

Kilitch Healthcare India Limited

Recalling firm
Kilitch Healthcare India Limited
Product type
Drug
Status
Ongoing
Report date
2024-02-14
Distribution
Nationwide within the United States
Product quantity
137,784 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Non-Sterility

Product description

CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

Code / lot info

All lots

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.