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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 10401–10420 of 17,793 recalls

Class IITerminated

HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06

Forest Laboratories, LLC

Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets

May 18, 2017 · DrugView details →

Class IIITerminated

Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01

Lantheus MI Radipharmaceuticals Inc.

Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent

May 18, 2017 · DrugView details →

Class IITerminated

fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32

SCA Pharmaceuticals

Lack of assurance of sterility: Product bags leaking at seam.

May 18, 2017 · DrugView details →

Class IITerminated

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

X-Gen Pharmaceuticals Inc.

Presence of Foreign Substance: potential presence of plastic particles.

May 17, 2017 · DrugView details →

Class IIITerminated

Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.

VistaPharm, Inc.

Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.

May 17, 2017 · DrugView details →

Class ITerminated

Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202

Lupin Limited (Unit 1)

Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.

May 16, 2017 · DrugView details →

Class IIOngoing

Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.

GlaxoSmithKline, LLC

Defective Delivery System: Elevated number of units with out of specification results for leak rate

May 16, 2017 · DrugView details →

Class IITerminated

Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48

Baxter Healthcare Corporation

Lack of assurance of sterility: customer complaints received for the presence of leaks.

May 15, 2017 · DrugView details →

Class IITerminated

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48

Baxter Healthcare Corporation

Lack of assurance of sterility: customer complaints received for the presence of leaks.

May 15, 2017 · DrugView details →

Class IITerminated

Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.

AtHome Medical, Inc.

GMP Deviations: The firm does not include an SOP for testing for out of specifications.

May 11, 2017 · DrugView details →

Class IITerminated

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

Zydus Pharmaceuticals USA Inc

Failed Dissolution Specifications

May 10, 2017 · DrugView details →

Class IITerminated

Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01

Zydus Pharmaceuticals USA Inc

Failed Dissolution Specifications

May 10, 2017 · DrugView details →

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