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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 381–400 of 436 recalls

Class IICompleted

Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, 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, 0.5 Fl. oz. (15 mL), Item #317916, 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

OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05

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

Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, 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 Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, 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 Ointment Sensitive Formula, Item#: 247885, 3.5 gram, 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

Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, 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

ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

July 2, 2019 · DrugView details →

Class IICompleted

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.

Apotex Inc.

Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

March 1, 2019 · DrugView details →

Class IICompleted

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03

Prinston Pharmaceutical Inc

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

January 18, 2019 · DrugView details →

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