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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 321–340 of 357 recalls

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 →

Class IICompleted

Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09

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 →

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 90 count NDC 43547-331-09

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 →

Class IICompleted

Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03

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 →

Class IICompleted

Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09

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 →

Class IICompleted

OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07

Allergan, PLC.

GMP Deviations: A silicone particulate was noted in Ozurdex.

December 20, 2018 · DrugView details →

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902

Hetero Labs Limited Unit V

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 8, 2018 · DrugView details →

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307

Hetero Labs Limited Unit V

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 8, 2018 · DrugView details →

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905

Hetero Labs Limited Unit V

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 8, 2018 · DrugView details →

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908

Hetero Labs Limited Unit V

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 8, 2018 · DrugView details →

Class IICompleted

Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.

Mckesson Packaging Services

Presence of Foreign Substance: foreign material found in the bulk inventory.

February 23, 2017 · DrugView details →

Class IICompleted

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

Boehringer Ingelheim Roxane Inc

Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.

April 2, 2015 · DrugView details →

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