D-0952-2017 Class II Terminated

Recalled by Phillips Co. — Millerton, OK

Recall Details

Product Type
Drugs
Report Date
July 12, 2017
Initiation Date
June 8, 2017
Termination Date
July 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20-50 bottles/units

Product Description

VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01

Reason for Recall

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

Distribution Pattern

Nationwide and United Kingdom

Code Information

All lots remaining within expiry.