DrKids Children's Allergy Relief Diphenhydramine Recalled for B. cepacia Contamination Risk
Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine HCl due to potential contamination with B. cepacia bacteria.
What this means for you
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 and is described as a precautionary measure due to potential contamination risk without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Unipharma, LLC is voluntarily recalling 1,060 cartons of DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, Mixed Berry. The product is identified by NDC 70302-012-20 and UPC 370302255010. The recall covers lots 80058 and 80060, which have an expiration date of 11/30/20.
The recall is being conducted as a precautionary measure due to current good manufacturing practice (CGMP) deviations that created a potential risk of product contamination with the bacteria B. cepacia. The affected product was distributed nationwide and in Venezuela.
Consumers who have purchased this product should stop using it and contact the manufacturer or their point of purchase for a refund or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 1,060
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 (3)
- Lots: 80058
- 80060
- Exp. 11/30/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Unipharma, Llc. 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.
See all 11 products in this recall →Related recalls
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FDA (Drugs) · 2019-08-14
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