Drug & medication recalls Moderate risk

Prescript Pharmaceuticals, Inc. recalls Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharma…

Recall date
April 24, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0807-2018
FDA classification
Class II
Brand / firm
Prescript Pharmaceuticals, Inc.
Sold / distributed
California.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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