Recalls / Class II
Class IID-1632-2019
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
- Affected lot / code info
- Lot: 90003 Exp. 01/31/21
Why it was recalled
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Recalling firm
- Firm
- Unipharma, Llc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10200 NW 67th St, N/A, Tamarac, Florida 33321-6404
Distribution
- Quantity
- 432 cartons
- Distribution pattern
- Nationwide in the US.
Timeline
- Recall initiated
- 2019-07-15
- FDA classified
- 2019-08-08
- Posted by FDA
- 2019-08-14
- Terminated
- 2020-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1632-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.