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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 10321–10340 of 17,793 recalls

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01

VistaPharm, Inc.

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

June 26, 2017 · DrugView details →

Class IITerminated

Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

ImprimisRx CA, Inc., dba ImprimisRx

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

June 23, 2017 · DrugView details →

Class IITerminated

Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

ImprimisRx CA, Inc., dba ImprimisRx

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

June 23, 2017 · DrugView details →

Class IITerminated

Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

ImprimisRx CA, Inc., dba ImprimisRx

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

June 23, 2017 · DrugView details →

Class IITerminated

Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA

ImprimisRx CA, Inc., dba ImprimisRx

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

June 23, 2017 · DrugView details →

Class IITerminated

QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.

Advanced Pharma Inc.

Lack of Assurance of Sterility

June 22, 2017 · DrugView details →

Class ITerminated

MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.

Vitility

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

June 22, 2017 · DrugView details →

Class IITerminated

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25

Advanced Pharma Inc.

Lack of Assurance of Sterility

June 22, 2017 · DrugView details →

Class IITerminated

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25

Advanced Pharma Inc.

Lack of Assurance of Sterility

June 22, 2017 · DrugView details →

Class IITerminated

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25

Advanced Pharma Inc.

Lack of Assurance of Sterility

June 22, 2017 · DrugView details →

Class IIITerminated

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06

Lupin Pharmaceuticals Inc.

Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.

June 22, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40

SCA Pharmaceuticals

Lack of sterility assurance

June 21, 2017 · DrugView details →

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