Recalls / Class II
Class IID-1631-2019
Product
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156
- Affected lot / code info
- Lot: 80060 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, N/A, Tamarac, Florida 33321-6404
Distribution
- Quantity
- 48 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-1631-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.