Status
Ongoing
Drug Enforcement D-0407-2025
cGMP deviations and lack of assurance of sterility.
Classification
Class II
Report Date
May 14, 2025
Termination Date
—
Product Information
- Product description
- Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
- Product quantity
- 13,104 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-0407-2025
- Event ID
- 96741
- Recall initiation date
- April 23, 2025
- Center classification date
- May 6, 2025
- Code info
- Lot, expiry: Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.
- More code info
- —