FDA recall D-0320-2015

K C Pharmaceuticals Inc · Class III · drug

Product

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) Equaline, DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344, UPC: 0 41163 25110 6; d) exact, Prepared For/Prepare Pour: Loblaws Inc., Montreal H4N 3L4, Tonronto M4T 2S8, Calgary T2E 7S9, CANADA, Imported by/Importe par: Arrow OTC, Mississauga, ON L5N 2B8, UPC: 0 60383 73613 2; e) FAMILY wellness, Distributed by: Family Dollar Services, Inc., 10401 Monroe Rd., Matthews, NC 28105, UPC: 0 32251 00459 9; f) Good Neighbor Pharmacy, Distributed By: AmerisourceBergen 1300 Moris Drive, Chesterbrook, PA 19087, UPC: 0 87701 14975 7, NDC: 24385-075-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00015 6, NDC: 48879-009-07; h) H-E-B, Made with Pride and Care for H-E

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).

Key facts

Status
Terminated
Initiation date
2014-12-04
Report date
2014-12-31
Termination date
2015-10-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pomona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2015