FDA Recalls For May 14, 2014

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

DRUG – CLASS II
Mangiacotti - Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, a) Lemon Verbena UPC 870678005306; b) Lavender UPC 870678005313; c) Ocean UPC 870678005320; d) Clementine UPC 870678005337; e) Pomegranate UPC 870678005344; f) Ginger Lime UPC 870678005351; all types: Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti.
Code: lot #s a & b) 13348; c, d & e) 13350; f) 13351.
Manufacturer:	Mangiacotti, Attleboro, MA
Recalled by:	Mangiacotti by telephone on Dec. 27, 2013. Firm-initiated recall is ongoing.
Distribution:	Nationwide; quantity N/A.
Reason:	Microbial contamination of non-sterile products: elevated counts of bacteria was found, Serratia liquefaciens.
Recall numbers:	D-1303- through D-1308-2014
DEVICE – CLASS III
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Code: lot #s GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.
Manufacturer:	Bausch & Lomb Inc., Greenville Solutions Plant, Greenville, SC
Recalled by:	Bausch & Lomb by letter on April 21, 2014. Firm-initiated recall is ongoing.
Distribution:	Nationwide U.S.; 256,440 bottles
Reason:	Out of specification results for one of the two disinfectants.
Recall numbers:	Z-1554-2014
EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences.