Recalls / Class II
Class IID-1299-2019
Product
DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019
- Affected lot / code info
- Lots: 80061 Exp. 11/30/20
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, Tamarac, Florida 33321-6404
Distribution
- Quantity
- 280 cartons
- Distribution pattern
- Nationwide and Venezuela
Timeline
- Recall initiated
- 2019-05-02
- FDA classified
- 2019-05-23
- Posted by FDA
- 2019-05-22
- Terminated
- 2020-11-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1299-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.