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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 7401–7420 of 17,773 recalls

Class IITerminated

Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

June 18, 2019 · DrugView details →
Class IITerminated

Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

June 18, 2019 · DrugView details →
Class IITerminated

Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

June 18, 2019 · DrugView details →
Class IITerminated

Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

June 18, 2019 · DrugView details →
Class IITerminated

Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

June 18, 2019 · DrugView details →
Class IITerminated

Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

June 18, 2019 · DrugView details →
Class IITerminated

Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

June 18, 2019 · DrugView details →
Class IIITerminated

Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.

Bausch & Lomb

Failed Stability Specifications: Out of specification for viscosity.

June 17, 2019 · DrugView details →
Class IITerminated

Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10

Golden State Medical Supply Inc.

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 14, 2019 · DrugView details →
Class IITerminated

Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30

Golden State Medical Supply Inc.

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 14, 2019 · DrugView details →
Class IITerminated

Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90

Golden State Medical Supply Inc.

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 14, 2019 · DrugView details →
Class IITerminated

Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90

Golden State Medical Supply Inc.

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 14, 2019 · DrugView details →
Class IITerminated

Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.

B. Braun Medical Inc

Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.

June 13, 2019 · DrugView details →
Class IITerminated

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64

Baxter Healthcare Corporation

Failed Stability Specifications

June 13, 2019 · DrugView details →
Class IITerminated

INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 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

Adcetris 96 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

DIPHENHYDRAMINE 25 MG/50 ML NS, 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

DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL 155 MG/ 250 ml NS IVPB; DOCETAXEL 110 mg / 250 ml NS IVPB; DOCETAXEL 150 MG / 250 ml NS IVPB; DOCETAXEL 137 mg / 250 ml 0.9% NACL IVPB; DOCETAXEL 130 MG/ 250 ml NS IVPB; DOCETAXEL 140 MG/ 250 ml NS IVPB; DOCETAXEL 144 MG/ 250 ML NS IVPB; DOCETAXEL 117 MG/ 250 ML NS IVPB; DOCETAXEL 30 mg / 250 ml D5W IVPB; DOCETAXEL 125 MG/ 250 ml NS IVPB; DOCETAXEL 135 MG / 250 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

TOPOTECAN 1.24 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

FERRIC CARBOXYMALTOSE 750mg/50ml 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 →
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