CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Chlorhexidine 12% liquid, 473 Milliters recalled
Prescript Pharmaceuticals is recalling Chlorhexidine 12% liquid, 473 Milliters, distributed in California. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0807-2018
- FDA event ID
- 79961
- Recalling firm
- Prescript Pharmaceuticals, Pleasanton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2018
- FDA classified
- 14 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 24 Apr 2018 | Recall initiated by company | |
| 14 May 2018 | Classified by FDA | +20 days |
| 23 May 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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
Where it was distributed
California.
Questions about this recall
Is Chlorhexidine 12% liquid, 473 Milliters recalled?
Yes. Prescript Pharmaceuticals recalled Chlorhexidine 12% liquid, 473 Milliters on 24 Apr 2018. The recall is Class II and its status is Terminated. Recall number D-0807-2018.
Why was it 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).
Which lots are affected?
Lot # 130128, EXP 08/31/20
Where was it sold?
California.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin, USP M-Pak containers recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA |
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| Drug | CLASS II | Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled | Prescript Pharmaceuticals | Foreign Material | CA |
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