← FDA ENFORCEMENT
D-0306-2024Class 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
7,200 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Non-Sterility

Product description

Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5

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.