Drug Recalls

Unipharma, Llc.

Class II Terminated

DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019

Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

D-1303-2019 May 22, 2019 Tamarac, FL

Unipharma, Llc.

Class II Terminated

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, ...

Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

D-1300-2019 May 22, 2019 Tamarac, FL

Unipharma, Llc.

Class II Terminated

DrKids 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...

Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

D-1298-2019 May 22, 2019 Tamarac, FL

Unipharma, Llc.

Class II Terminated

CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, ...

Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

D-1302-2019 May 22, 2019 Tamarac, FL

Unipharma, Llc.

Class II Terminated

CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy...

Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

D-1296-2019 May 22, 2019 Tamarac, FL

Medi-Physics Inc. dba GE Healthcare

Class III Terminated

Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington...

Reason: Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.

D-1134-2019 April 17, 2019 Arlington Heights, IL

Johnson Matthey Inc.

Class II Terminated

Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

Reason: Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.

D-1077-2019 April 10, 2019 West Deptford, NJ

Ecolab Inc

Class II Terminated

Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33

Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

D-1062-2019 April 3, 2019 Saint Paul, MN

Ecolab Inc

Class II Terminated

Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49

Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

D-1064-2019 April 3, 2019 Saint Paul, MN

Ecolab Inc

Class II Terminated

Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul...

Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

D-1061-2019 April 3, 2019 Saint Paul, MN

Ecolab Inc

Class II Terminated

Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-3...

Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

D-1060-2019 April 3, 2019 Saint Paul, MN

Ecolab Inc

Class II Terminated

Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85

Reason: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

D-1063-2019 April 3, 2019 Saint Paul, MN

King Bio Inc.

Class I Terminated

Dr. King's SafeCare Rx Personality Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955105022, NDC 57955-1053-2