FDAMay 2, 2019drug
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
What to do
FDA enforcement status: Terminated
Brands named
unipharma
UPCs
050428597156
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 333212019-09-23
- FDADrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 3703024890262019-09-23
- FDACVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 0504285982072019-07-15
- FDACVS 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...2019-07-15
- FDADrKids 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 3703022550102019-07-15
- FDADrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 3703022550102019-05-02
- FDADrKids 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 3703022230192019-05-02
- FDADrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 3703022680102019-05-02
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