Unipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk
Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine vials due to a precautionary measure regarding 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 explicitly described as a 'precautionary measure' due to potential contamination, with no reported illnesses or injuries, which aligns with the rubric criteria for Moderate severity (voluntary precautionary recalls).
Plain-English summary
Unipharma, LLC is recalling 432 cartons of DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor. The product consists of 20 pre-measured single-use vials per carton and was distributed nationwide in the US. The specific lot affected is 90003 with an expiration date of 01/31/21.
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 source text does not report any specific illnesses or injuries associated with this recall.
Consumers who have this product should stop using it and contact Unipharma, LLC for further instructions or a refund.
The recalled product
- Product
- DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 432
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 (1)
- Lot: 90003 Exp. 01/31/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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