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💊 Drugs • 3,200 recalls

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 →

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 →

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Meditech Laboratories

Class I - Dangerous

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Mar 14, 2016 Other Drugs Nationwide View Details →

UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,

Praxair

Class I - Dangerous

CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

Sep 16, 2015 Other Drugs Nationwide View Details →

UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.

Praxair

Class I - Dangerous

CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.

Sep 16, 2015 Other Drugs Nationwide View Details →

RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA

Tf Supplements

Class I - Dangerous

Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.

Sep 25, 2015 Other Drugs Nationwide View Details →

Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748

Tf Supplements

Class I - Dangerous

Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.

Sep 25, 2015 Other Drugs Nationwide View Details →

sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654

J. Strickland and

Class I - Dangerous

Subpotent Drug: failed at the 3 and 6 month stability time points.

Feb 11, 2016 Other Drugs Nationwide View Details →

Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5.

Keystone Laboratories

Class I - Dangerous

Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.

Feb 8, 2016 Other Drugs Nationwide View Details →

TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8.

Alcon Research

Class I - Dangerous

Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.

Feb 9, 2016 Other Drugs Nationwide View Details →

fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium

Pharmedium Services

Class I - Dangerous

Subpotent Drug

Jan 13, 2015 Other Drugs View Details →

Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA.

MSNV, Inc

Class I - Dangerous

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Oct 1, 2015 Other Drugs Nationwide View Details →

Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA

Premiere Sales Group

Class I - Dangerous

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Sep 30, 2015 Other Drugs Nationwide View Details →

fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.

Pharmedium Services

Class I - Dangerous

Subpotent Drug

Jan 13, 2015 Other Drugs View Details →

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