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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 3881–3900 of 17,755 recalls

Class IITerminated

PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.

Vitae Enim Vitae Scientific, Inc.

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

March 14, 2022 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15

Athenex Pharma Solutions, LLC

Defective container

March 14, 2022 · DrugView details →

Class IITerminated

Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.

DASH Pharmaceuticals LLC

Labeling: Label Mix-Up

March 11, 2022 · DrugView details →

Class IIITerminated

Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.

Macleods Pharma Usa Inc

FAILED CONTENT UNIFORMITY SPECIFICATIONS

March 10, 2022 · DrugView details →

Class IITerminated

ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202

Rock Town Distillery, Inc.

CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.

March 10, 2022 · DrugView details →

Class IITerminated

Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sub Potent

March 8, 2022 · DrugView details →

Class ITerminated

Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06

Jubilant Cadista Pharmaceuticals, Inc.

Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride

March 8, 2022 · DrugView details →

Class IIITerminated

Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sub Potent

March 8, 2022 · DrugView details →

Class IITerminated

Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00

Olympia Compounding Pharmacy dba Olympia Pharmacy

Super Potent and Failed Reconstitution Time

March 8, 2022 · DrugView details →

Class IIITerminated

T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Super Potent

March 8, 2022 · DrugView details →

Class IIITerminated

Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sub Potent

March 8, 2022 · DrugView details →

Class IIITerminated

SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sub Potent

March 8, 2022 · DrugView details →

Class IITerminated

NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835 NDC: 73198-0083-00

Olympia Compounding Pharmacy dba Olympia Pharmacy

Product found to be Sub Potent or Exceeded reconstitution time

March 8, 2022 · DrugView details →

Class IIOngoing

GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

March 7, 2022 · DrugView details →

Class IIOngoing

Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

March 7, 2022 · DrugView details →

Class IIOngoing

Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

March 7, 2022 · DrugView details →

Class IIOngoing

Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

March 7, 2022 · DrugView details →

Class IIOngoing

Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

March 7, 2022 · DrugView details →

Class IIOngoing

Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

March 7, 2022 · DrugView details →

Class IIOngoing

Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

March 7, 2022 · DrugView details →

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