Polyvinyl Alcohol Solution/ Drops
FDA Recall NDC 50268-678
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Polyvinyl Alcohol (NDC 50268-678). A significant event, classified as Class II, was initiated on Apr 23, 2025 by Avpak. The reported reason for this action was: "cGMP deviations and lack of assurance of sterility."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2025 Class II Recall: cGMP deviations and lack of assurance of sterility.
Recall Number
Class II Ongoing
cGMP deviations and lack of assurance of sterility.
Apr 23, 2025
May 14, 2025
14,333 cases (24 cartons per case)
Recall Profile & Regulatory Data
Event ID
96741
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
BRS Analytical Services, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.
Affected Packages Involved in this Recall
50268-678-15Product
Class III Ongoing
LABELING: LABEL MIX-UP
Dec 18, 2024
Jan 08, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96032
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Batch or Lot Expiration Information
Lot# : 0160, Exp. Date April 26 2026
Affected Packages Involved in this Recall
50268-678-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
