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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

Centro Naturista

Class I - Dangerous

Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.

Jun 3, 2015 Prescription Drugs Nationwide View Details →

col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.

Allegiant Health

Class I - Dangerous

Superpotent Drug: High out of specification results for assay at the 6 month time point interval.

Feb 29, 2016 Other Drugs Nationwide View Details →

BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.

Keystone Laboratories

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: Failed S.aureus test.

Apr 4, 2016 Other Drugs View Details →

Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03

TMIG

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.

Mar 23, 2016 Prescription Drugs Nationwide View Details →

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

Hospira

Class I - Dangerous

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

Mar 23, 2016 Prescription Drugs Nationwide View Details →

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

Mylan Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specifications; three month stability time point.

Feb 12, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Impurities/Degradation Specifications; 12 month stability time point

Mar 30, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87

Baxter Healthcare

Class I - Dangerous

Discoloration: presence of atypical yellow discoloration of the solution .

Apr 12, 2016 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

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

Class I - Dangerous

cGMP Deviations; product does not comply with cGMP requirements

Oct 15, 2015 Other Drugs View Details →

Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.

Akorn

Class I - Dangerous

Presence of Particulate Matter

Apr 7, 2016 Compounded Drugs Nationwide View Details →

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.

Bryant Ranch Prepack

Class I - Dangerous

Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

Mar 25, 2016 Prescription Drugs Nationwide View Details →