Drug & medication recalls High risk

CVS Health brand Lubricant Eye Drops recalled over sterility concerns

Recall date
November 13, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Kilitch Healthcare India Limited recalls CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (N…
Recall number
D-0292-2024
FDA classification
Class I
Brand / firm
Kilitch Healthcare India Limited
Sold / distributed
Nationwide within the United States

Why it was recalled

Non-Sterility

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.

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