Drug product

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

D-0807-2018

April 24, 2018

Class II

Product summary

Firm: Prescript Pharmaceuticals, Inc.
Event: Event 79961
Status: Terminated
Classification: Class II
Quantity: 24 473-ml bottles
Official record key: drug-enforcement:D-0807-2018

Official wording

Reason: 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).

Code information: Lot # 130128, EXP 08/31/20

Distribution pattern: California.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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).