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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 13841–13860 of 17,832 recalls

Class ITerminated

Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50

Pharmedium Services, LLC

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

January 28, 2015 · DrugView details →

Class ITerminated

Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50

Pharmedium Services, LLC

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

January 28, 2015 · Drug

View details →

Class IITerminated

Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.

AnazaoHealth Corporation

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

January 26, 2015 · FDAView details →

Class ITerminated

AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1.

Detox Transforms

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.

January 25, 2015 · DrugView details →

Class ITerminated

iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.

Detox Transforms

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.

January 25, 2015 · DrugView details →

Class ITerminated

EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.

Detox Transforms

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.

January 25, 2015 · DrugView details →

Class ITerminated

BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.

Detox Transforms

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.

January 25, 2015 · DrugView details →

Class ITerminated

iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.

Detox Transforms

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.

January 25, 2015 · DrugView details →

Class IIITerminated

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

Mylan Institutional LLC

Subpotent Drug and Failed Impurities/Degradation Specifications

January 23, 2015 · DrugView details →

Class IITerminated

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

Hospira Inc.

Crystallization

January 23, 2015 · DrugView details →

Class IITerminated

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Hospira Inc.

Crystallization

January 23, 2015 · DrugView details →

Class IITerminated

Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86

Sun Pharma Global Fze

Failed Dissolution Specifications: 6 month time point.

January 21, 2015 · DrugView details →

Class IITerminated

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.

Sun Pharma Global Fze

Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.

January 21, 2015 · DrugView details →

Class ITerminated

0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02

Hospira Inc.

Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.

January 20, 2015 · DrugView details →

Class ITerminated

Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

Pacifico National, Inc. dba AmEx Pharmacy

Non-Sterility: Product tested positive for bacterial contamination.

January 20, 2015 · DrugView details →

Class ITerminated

Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

Pacifico National, Inc. dba AmEx Pharmacy

Non-Sterility: Product tested positive for bacterial contamination.

January 20, 2015 · DrugView details →

Class ITerminated

fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium

Pharmedium Services, LLC

Subpotent Drug

January 13, 2015 · DrugView details →

Class ITerminated

fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.

Pharmedium Services, LLC

Subpotent Drug

January 13, 2015 · DrugView details →

Class IITerminated

Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3

Noven Pharmaceuticals, Inc.

Defective Delivery System: One lot exceeded the mechanical peel specification

January 12, 2015 · DrugView details →

Class IIITerminated

5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China

Freedom Pharmaceuticals Inc

Subpotent Drug

January 8, 2015 · DrugView details →

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