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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 12381–12400 of 17,816 recalls

Class IITerminated

Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Downing Labs, LLC

Lack of Assurance of Sterility

October 16, 2015 · DrugView details →

Class IITerminated

Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Downing Labs, LLC

Lack of Assurance of Sterility

October 16, 2015 · DrugView details →

Class II

Terminated

Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Downing Labs, LLC

Lack of Assurance of Sterility

October 16, 2015 · DrugView details →

Class IIOngoing

Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIOngoing

Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1

Sesderma, SL

cGMP Deviations; product does not comply with cGMP requirements

October 15, 2015 · DrugView details →

Class IIITerminated

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10

Rx PAK

Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.

October 13, 2015 · DrugView details →

Class IITerminated

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01

Mutual Pharmaceutical Company, Inc.

Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

October 9, 2015 · DrugView details →

Class IITerminated

Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013

Qualgen

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

October 9, 2015 · DrugView details →

Class IITerminated

Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013

Qualgen

Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.

October 9, 2015 · DrugView details →

Class IITerminated

PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Pacific Healthcare, Inc dba B&B Pharmacy

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

October 7, 2015 · DrugView details →

Class IITerminated

PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Pacific Healthcare, Inc dba B&B Pharmacy

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

October 7, 2015 · DrugView details →

Class IITerminated

PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Pacific Healthcare, Inc dba B&B Pharmacy

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

October 7, 2015 · DrugView details →

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