FDAClass IINovember 27, 2019

CVS Health Preservative Free Lubricant Eye Drops recall: Sterility Concern

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Why was CVS Health Preservative Free Lubricant Eye Drops recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: QHI 08/19 QJG 10/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 SBF 2/21 SDD 04/21

Product
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
77,760 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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