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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 7701–7720 of 17,773 recalls

Class IITerminated

NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class II

Terminated

Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

Lack of sterility assurance.

April 12, 2019 · DrugView details →

Class IITerminated

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA

Dr. Reddy's Laboratories, Inc.

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

April 11, 2019 · DrugView details →

Class IIITerminated

Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01

LUPIN SOMERSET

Failed Impurities/Degradation Specifications

April 10, 2019 · DrugView details →

Class IIITerminated

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01

LUPIN SOMERSET

Failed Impurities/Degradation Specifications

April 10, 2019 · DrugView details →

Class IIITerminated

Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01

LUPIN SOMERSET

Failed Impurities/Degradation Specifications

April 10, 2019 · DrugView details →

Class IIITerminated

Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01

LUPIN SOMERSET

Failed Impurities/Degradation Specifications

April 10, 2019 · DrugView details →

Class IIITerminated

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01

LUPIN SOMERSET

Failed Impurities/Degradation Specifications

April 10, 2019 · DrugView details →

Class ITerminated

Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135

SELECT DISTRIBUTIONS LLC

Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil

April 9, 2019 · DrugView details →

Class IITerminated

BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Customceutical Compounding

Lack of assurance of sterility for injectables and solutions intended to be sterile.

April 8, 2019 · DrugView details →

Class IITerminated

GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21

American Health Packaging

Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.

April 8, 2019 · DrugView details →

Class IITerminated

HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Customceutical Compounding

Lack of assurance of sterility for injectables and solutions intended to be sterile.

April 8, 2019 · DrugView details →

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