Prescript Pharmaceuticals Recalls Chlorhexidine Liquid Due to Labeling Error
Prescript Pharmaceuticals is recalling Chlorhexidine 0.12% liquid due to a storage temperature labeling discrepancy. The product was distributed in California.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a minor labeling error regarding storage temperatures, which fits the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Prescript Pharmaceuticals, Inc. is recalling 24 bottles of 473-milliliter Chlorhexidine 0.12% liquid. The recall is due to a labeling error where the storage temperature declaration on the label differs from the original manufacturer's declaration. The label states to store at 15°C to 30°C (59°F to 86°F), while the original manufacturer declaration specifies storage at 20°C to 25°C (68°F to 77°F).
The affected product is Lot # 130128 with an expiration date of 08/31/20. The product was distributed in California. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- 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
- Manufacturer
- Prescript Pharmaceuticals, Inc.
- Category
- Drug — Antiseptic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 130128
- EXP 08/31/20
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Prescript Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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