Reported Aug 14, 2019 · Terminated
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine,…
Unipharma, Llc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Unipharma, Llc. · 10200 NW 67th St · Tamarac, FL · 33321-6404
Is this the product you have?
- 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 byCVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156
- Lot codes and dates
- Lot80060 Exp. 11/30/20
- Amount recalled
- 48 cartons
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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