RecallRadar

FDA Drug recall D-0807-2018

Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only

On 2018-05-23 the FDA classified a Class II recall of Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only by Prescript Pharmaceuticals, citing 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¿….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0807-2018
ClassificationClass II
Statusterminated
Initiated2018-04-24
Published2018-05-23
Last updated2026-09-13 11:52 UTC
CompanyPrescript Pharmaceuticals
DistributionCA

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

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).

Identifiers

code_infoLot # 130128, EXP 08/31/20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0807-2018%22

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