Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3; b) CVP, Distributed by Salado Sales, Inc., Temple, Texas 76503, UPC: 7 61706 16500 3; c) Equ
Check against the official notice below — it lists the full affected range.
K C Pharmaceuticals Inc is recalling Best Choice brand eye drops (Tetrahydrozoline HCl 0.05%) in 0.5 FL OZ bottles distributed by Valu Merchandisers Co. The recall affects 751,440 bottles sold nationwide in the U.S. and in Ontario, Canada. The recall was issued because the active pharmaceutical ingredient used to manufacture the product was stored in a warehouse that did not comply with Good Manufacturing Practice (GMP) standards at a facility in Italy.
The recalled product includes eight lot numbers with expiration dates ranging from January 2016 to April 2016: Lots 3A001, 3A002, 3B003, 3B004, 3C005, 3C006, 3D007, and 3D008. The source does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Reason for recall: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. Distribution: U.S. Nationwide and Canada (Ontario). Quantity: 751,440 Bottles Lot/code info: Lot #: 3A001, Expiry: 01/16; Lot #: 3A002, Expiry: 01/16; Lot #: 3B004, Expiry: 02/16; Lot #: 3B003, Expiry: 02/16; Lot #: 3C005, Expiry: 03/16; Lot #: 3C006, Expiry: 03/16; Lot #: 3D007, Expiry: 04/16; Lot #: 3D008, Expiry: 04/16.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.