D-0807-2018 Class II Terminated

Recalled by Prescript Pharmaceuticals, Inc. — Pleasanton, CA

Recall Details

Product Type
Drugs
Report Date
May 23, 2018
Initiation Date
April 24, 2018
Termination Date
January 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 473-ml bottles

Product Description

Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482

Reason for Recall

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

Distribution Pattern

California.

Code Information

Lot # 130128, EXP 08/31/20