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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 3501–3520 of 17,723 recalls

Class IICompleted

Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0064-30

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0088-10.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0083-00.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IIOngoing

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3

Noven Pharmaceuticals Inc

Defective Delivery System: customer complaints exceeded respective action limits.

May 6, 2022 · DrugView details →
Class IITerminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.

SUN PHARMACEUTICAL INDUSTRIES INC

Lack of assurance of sterility

May 6, 2022 · DrugView details →
Class IITerminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.

SUN PHARMACEUTICAL INDUSTRIES INC

Lack of assurance of sterility

May 6, 2022 · DrugView details →
Class IITerminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40.

SUN PHARMACEUTICAL INDUSTRIES INC

Lack of assurance of sterility

May 6, 2022 · DrugView details →
Class IITerminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01.

SUN PHARMACEUTICAL INDUSTRIES INC

Lack of assurance of sterility

May 6, 2022 · DrugView details →
Class IITerminated

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.

SUN PHARMACEUTICAL INDUSTRIES INC

Lack of assurance of sterility

May 6, 2022 · DrugView details →
Class IITerminated

Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90

Direct Rx

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

May 5, 2022 · DrugView details →
Class IITerminated

Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800 9

Vi-Jon, LLC

Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.

May 5, 2022 · DrugView details →
Class IITerminated

Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

RemedyRepack Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

May 4, 2022 · DrugView details →
Class IIITerminated

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

American Health Packaging

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

May 3, 2022 · DrugView details →
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