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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 7621–7640 of 17,773 recalls

Class IITerminated

Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10

Heritage Pharmaceuticals, Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 3, 2019 · DrugView details →
Class IITerminated

Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10

Heritage Pharmaceuticals, Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 3, 2019 · DrugView details →
Class IITerminated

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

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

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, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

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 33321, NDC 70302-012-20, UPC 370302255010

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

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, UPC 050428597958

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

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

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116

Septodont Inc.

Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.

May 2, 2019 · DrugView details →
Class IITerminated

DrKids 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 370302268010

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

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

Unipharma, Llc.

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

May 2, 2019 · DrugView details →
Class IITerminated

Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated

Golden State Medical Supply Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 1, 2019 · DrugView details →
Class IITerminated

Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated

Golden State Medical Supply Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 1, 2019 · DrugView details →
Class IITerminated

Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated

Golden State Medical Supply Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 1, 2019 · DrugView details →
Class IITerminated

Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated

Golden State Medical Supply Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 1, 2019 · DrugView details →
Class IITerminated

Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated

Golden State Medical Supply Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

May 1, 2019 · DrugView details →
Class IITerminated

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02

Sagent Pharmaceuticals Inc

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

April 30, 2019 · DrugView details →
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