Status
Ongoing
Drug Enforcement D-0408-2025
cGMP deviations and lack of assurance of sterility.
Classification
Class II
Report Date
May 14, 2025
Termination Date
—
Product Information
- 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.
- Product quantity
- 14,333 cases (24 cartons per case)
- Reason for recall
- cGMP deviations and lack of assurance of sterility.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- BRS Analytical Services, LLC
- Address
-
11697 Lakeside Crossing Ct, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0408-2025
- Event ID
- 96741
- Recall initiation date
- April 23, 2025
- Center classification date
- May 6, 2025
- Code info
- 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.
- More code info
- —