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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 7481–7500 of 17,773 recalls

Class IITerminated

DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class II

Terminated

CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 895 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 235 MG / 250ml NS IVPB CARBOPLATIN 716 MG / 250 ML D5W IVPB; CARBOPLATIN 400 MG / 500 ML NS IVPB; CARBOPLATIN 500 MG / 100 ML NACL 0.9% IVPB; CARBOPLATIN 575 MG / 500 ML NS IVPB; CARBOPLATIN 307 MG / 100 ML NACL 0.9% IVPB; CARBOPLATIN 766 MG / 500 ML NS IVPB; CARBOPLATIN 684 / 250 ML NACL 0.9% IVPB; CARBOPLATIN 260 MG / 100 ML D5W IVPB CARBOPLATIN 360 MG /100 ML NACL 0.9% IVPB; CARBOPLATIN 274 MG / 250 ML D5W IVPB; CARBOPLATIN 240 MG / 100 ML D5W IVPB; CARBOPLATIN 750 MG / 250 ML NS IVPB; CARBOPLATIN 260 MG / 250 ML NS IVPB; CARBOPLATIN 460 MG / 250 ML NS IVPB; CARBOPLATIN 175 MG / 250 ML NS IVPB; CARBOPLATIN 229.4 MG / 500 ML NS IVPB CARBOPLATIN 780 MG / 100 ML NACL 0.9% IVPB; CARBOPLATIN 140 MG / 250 ML NS IVPB; CARBOPLATIN 408 MG / 500 ML NS IVPB CARBOPLATIN 847 MG / 250 ML D5W IVPB; CARBOPLATIN 560 MG / 250 ML D5W IVPB; CARBOPLATIN 180 MG / 250 ML NS IVPB; CARBOPLATIN 200 MG / 250 ML D5W IVPB; CARBOPLATIN 238 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; Fluorouracil 3920 MG QS 92 ML 0.9% NACL; Fluorouracil 3760 mg QS 100 ml NS CASS; Fluorouracil 4000 MG QS 92 ml 0.9% NACL; Fluorouracil 3140 MG QS 240 ML NS PUMP; Fluorouracil 2400 MG QS 96 ML 0.9% NACL Fluorouracil 5000 MG QS 101 ml 0.9% NACL; Fluorouracil 750 MG / 15 ML IVP Fluorouracil 4500 mg QS 100 ml NS CASS; Fluorouracil 4100 mg QS 100 ml NS CASS; Fluorouracil 690 mg / 13.8 ml IVP; Fluorouracil 2400 MG QS 96 ML NS IV; Fluorouracil 812 MG/16.24 ML IVP; Fluorouracil 4872 MG QS 240 ML NS PUMP; Fluorouracil 4200 mg QS 100 ml NS CASS; Fluorouracil 1110 MG QS 96 ml NS IVPB; Fluorouracil 370 MG/ 50 ML NS; Fluorouracil 620 MG/ 12.4 ML SYRINGE IVP; Fluorouracil 3160 MG QS 92 ML 0.9% NACL; Fluorouracil 1050 mg QS 92 ml NS IVPB; Fluorouracil 370 MG /100 ML NS IVPB; Fluorouracil 4080 MG QS 1000 ML NS IVPB; Fluorouracil 5 MG / 0.1 ML SYRINGE; Fluorouracil 5040 MG QS 101 ml NS CADD; Fluorouracil 4224 MG QS 100 ml NS CASS; Fluorouracil 700 MG / 14 ML IVP; Fluorouracil 3550 mg QS 92 ML 0.9% NACL IV; Fluorouracil 760 MG / 15.2 ML IVP; Fluorouracil 4560 MG QS 240 ML NS PUMP; Fluorouracil 796 MG / 15.92 MLIVP Fluorouracil 4776 MG QS 240 ML NS PUMP; Fluorouracil 930 MG QS 240 ML NS PUMP; Fluorouracil 730 MG / 14.6 ML IVP SYR; Fluorouracil 4400 MG QS 100 ml NS CADD; Fluorouracil 2430 MG QS 96 ml 0.9% NACL; Fluorouracil 4728 MG QS 100 ml NS CASS; Fluorouracil 3550 MG QS 92 ML 0.9% NACL Fluorouracil 588 MG / 11.76 ML IVP; Fluorouracil 3528 MG QS 240 ML NS PUMP; Fluorouracil 2520 mg QS 96 ml NS IVPB; Fluorouracil 790 MG / 15.8 ml IVP; Fluorouracil 4750 mg QS 97 ml 0.9% NACL IV; Fluorouracil 2660 MG QS 96 ml NS IVPB; Fluorouracil 720 MG/ 14.4 ML IVP; Fluorouracil 4370 mg QS 92 ml 0.9% NACL IV; Fluorouracil 3280 MG QS 92 ML 0.9% NACL; Fluorouracil 780 MG / 15.6 ML IVP; Fluorouracil 4660 MG QS 97 ml 0.9% NACL Fluorouracil 3620 MG QS 100 ml NS CASS; Fluorouracil 2370 MG QS 92 ML 0.9% NACL; Fluorouracil 800 MG / 16 ML IVP; Fluorouracil 4800 MG QS 101 ml NS CADD; Fluorouracil 4000 mg QS 92 ML 0.9% NACL IV; Fluorouracil 2480 MG QS 96 ML 0.9% NACL; Fluorouracil 688 MG / 13.76 ml IVP Fluorouracil 4128 MG QS 1000 ML D5W IVPB; Fluorouracil 6000 MG QS 250 ml NS CASS; Fluorouracil 672 MG / 13.44 ML IVP; Fluorouracil 4032 MG / 1000 ML D5W IVPB; Fluorouracil 894 MG / 17.88 ml IVP; Fluorouracil 400 MG / 50 ML NS IVPB; Fluorouracil 840 MG / 16.8 ml IVP; Fluorouracil 590 MG/ 11.8 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBULIN 1.89 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OXALIPLATIN 130 MG / 250 ML D5W IVPB; OXALIPLATIN 140 MG / 250 ml D5W IVPB; OXALIPLATIN 162 MG / 250 ML D5W IVPB; OXALIPLATIN 169 MG / 250 ML D5W IVPB; OXALIPLATIN 90 MG / 500 ML D5W IVPB; OXALIPLATIN 50 MG / 250 ML D5W IVPB; OXALIPLATIN 70 MG / 500 ML D5W IVPB; OXALIPLATIN 40 MG / 250 ML D5W IVPB; OXALIPLATIN 155 MG / 250 ML D5W IVPB; OXALIPLATIN 85 MG / 250 ML D5W IVPB OXALIPLATIN 146 MG / 250 ML D5W IVPB; OXALIPLATIN 246 MG / 500 ML D5W IVPB; OXALIPLATIN 143 MG / 250 ML D5W IVPB; OXALIPLATIN 65 MG / 500 ML D5W IVPB; OXALIPLATIN 80 MG / 500 ML D5W IVPB; OXALIPLATIN 100 MG / 250 ML D5W IVPB; OXALIPLATIN 150 MG / 250 ML D5W IVPB; OXALIPLATIN 125 MG / 250 ML D5W IVPB; OXALIPLATIN 170 MG / 250 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IITerminated

PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.

Lack of Assurance of Sterility

June 12, 2019 · DrugView details →

Class IIITerminated

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44

InvaGen Pharmaceuticals, Inc.

Defective Container; actuator may improperly function and affect dose delivery.

June 12, 2019 · DrugView details →

Class IITerminated

Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01

Preferred Pharmaceuticals, Inc

CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

June 10, 2019 · DrugView details →

Class IIITerminated

Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13

Akorn Inc

Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

June 7, 2019 · DrugView details →

Class ITerminated

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78

PharMEDium Services, LLC

Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite

June 7, 2019 · DrugView details →

Class IIOngoing

LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00

Teva Pharmaceuticals USA

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

June 6, 2019 · DrugView details →

Class IIOngoing

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

Teva Pharmaceuticals USA

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

June 6, 2019 · DrugView details →

Class IITerminated

Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1

Sun Pharmaceutical Industries, Inc.

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

June 5, 2019 · DrugView details →

Class IITerminated

Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.

P & L Developments, LLC

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

June 5, 2019 · DrugView details →

Class IITerminated

Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.

P & L Developments, LLC

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

June 5, 2019 · DrugView details →

Class IITerminated

Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.

P & L Developments, LLC

cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

June 5, 2019 · DrugView details →

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