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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 7121–7140 of 17,773 recalls

Class IITerminated

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1

LNK International, Inc.

Microbial contamination of non-sterile product

July 10, 2019 · DrugView details →

Class IITerminated

Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.

Pfizer Inc.

Lack of Assurance of Sterility: Bags have the potential to leak.

July 9, 2019 · DrugView details →

Class ITerminated

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

Jubilant Cadista Pharmaceuticals, Inc.

Failed dissolution specifications : failed results at the 3-month stability time point.

July 9, 2019 · DrugView details →

Class IITerminated

Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.

Pfizer Inc.

Lack of Assurance of Sterility: Bags have the potential to leak.

July 9, 2019 · DrugView details →

Class IITerminated

Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01

Piramal Critical Care, Inc.

Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.

July 8, 2019 · DrugView details →

Class IICompleted

CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

TRP Pink Eye Relief, 10 mL, NDC 17312-013-15

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

TRP Blur Relief, 15 mL, NDC 17312-002-11

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39945 3

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

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