FDA Drug Recalls

14,801 recalls, newest first

Class III · Low risk Terminated Jul 28, 2015

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 24385-0161-52 D-0027-2016

Class III · Low risk Terminated Jul 28, 2015

Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0026-2016

Class III · Low risk Terminated Jul 28, 2015

Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 41163-528-69 D-0025-2016

Class III · Low risk Terminated Jul 28, 2015

Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0024-2016

Class III · Low risk Terminated Jul 28, 2015

CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0023-2016

Class III · Low risk Terminated Jul 28, 2015

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 41520-525-69 D-0022-2016

Class III · Low risk Terminated Jul 28, 2015

Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0021-2016

Class III · Low risk Terminated Jul 28, 2015

Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. D-0020-2016

Class III · Low risk Terminated Jul 28, 2015

QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc…

Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.

Ohm Laboratories, Inc. NDC 63868-157-10 D-0019-2016

Class II · Moderate risk Terminated Jul 27, 2015

Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for…

Reason Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.

Noven Pharmaceuticals, Inc. D-0008-2016

Class I · High risk Terminated Jul 24, 2015

ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva…

Reason Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution

Teva Pharmaceuticals USA NDC 0703-3019-12 D-1351-2015

Class II · Moderate risk Terminated Jul 24, 2015

univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.

Reason Failed Dissolution Testing: Failed 24 month dissolution testing.

Ucb, Inc D-1348-2015

Class III · Low risk Terminated Jul 24, 2015

Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC…

Reason Failed Dissolution Specifications

Shionogi Inc. NDC 59630-501-10 D-1284-2015

Class II · Moderate risk Terminated Jul 24, 2015

COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered…

Reason Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

Boehringer Ingelheim Roxane Inc NDC 0597-0024-02 D-1279-2015

Class II · Moderate risk Terminated Jul 24, 2015

VITAMIN D3 OIL, Injectable Solution, 50,000 UNITS/ML, syringe sizes: 10 mL and 30 mL, Rx only,JD & SN Inc, DBA Moses Lake…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0155-2016

Class II · Moderate risk Terminated Jul 24, 2015

VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0154-2016

Class II · Moderate risk Terminated Jul 24, 2015

VITAMIN B-COMPLEX, Injectable Solution, Syringe size: 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0153-2016

Class II · Moderate risk Terminated Jul 24, 2015

TRIMIX, injectable Solution, 40MG/2MG/40MCG/ML, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0152-2016

Class II · Moderate risk Terminated Jul 24, 2015

TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0151-2016

Class II · Moderate risk Terminated Jul 24, 2015

TRIMIX, injectable Solution, 30MG/1MG/20MCG, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0150-2016

Class II · Moderate risk Terminated Jul 24, 2015

TRIMIX, injectable Solution, 30MG/1MG/10MCG, syringe sizes: 5 mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0149-2016

Class II · Moderate risk Terminated Jul 24, 2015

TRIMIX, injectable Solution, 20MG/1MG/20MCG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0148-2016

Class II · Moderate risk Terminated Jul 24, 2015

TRIMIX, injectable Solution, 15MG/.5MG/5MCG/ML, 10mL syringe, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0147-2016

Class II · Moderate risk Terminated Jul 24, 2015

TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0146-2016

Class II · Moderate risk Terminated Jul 24, 2015

TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses…

Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

JD & SN Inc., dba Moses Lake Professional Pharmacy D-0145-2016