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FDA Drug Recalls

2,661 recalls, newest first

Class I · High risk Ongoing Mar 18, 2016

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045…

Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Hospira Inc. NDC 0409-6625-02 D-0865-2016

Class III · Low risk Ongoing Mar 15, 2016

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label…

Hospira Inc. NDC 0409-6629-02 D-0836-2016

Class III · Low risk Ongoing Feb 2, 2016

Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container…

Hospira Inc. NDC 0409-7965-09 D-0727-2016

Class I · High risk Ongoing Dec 29, 2015

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical…

Reason Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

Complete Pharmacy and Medical Solutions LLC D-0917-2017

Class I · High risk Ongoing Dec 23, 2015

APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA…

Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved…

Nuway Distributors, LLC D-0667-2016

Class I · High risk Ongoing Nov 6, 2015

Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/chol…

Reason Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).

Glades Drugs Inc. D-0669-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL D-0851-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL D-0850-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL NDC 63181-0010-1 D-0849-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL NDC 63181-0011-1 D-0848-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL NDC 16047-0029-1 D-0847-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL NDC 63181-0019-1 D-0846-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL NDC 63181-0012-1 D-0845-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL)…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL NDC 63181-0013-1 D-0844-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL D-0843-2016

Class II · Moderate risk Ongoing Oct 15, 2015

Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma…

Reason cGMP Deviations; product does not comply with cGMP requirements

Sesderma, SL NDC 63181-0015-1 D-0842-2016

Class III · Low risk Ongoing Sep 29, 2015

Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter…

Reason Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability…

Hospira Inc. NDC 0409-8060-29 D-0054-2016

Class I · High risk Ongoing Aug 27, 2015

MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.

Reason Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in…

The One Minute Miracle Inc D-0230-2016

Class I · High risk Ongoing Aug 27, 2015

MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One…

Reason Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male…

The One Minute Miracle Inc D-0229-2016

Class II · Moderate risk Ongoing Aug 25, 2015

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL…

Reason Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

Hospira, Inc. NDC 0409-4279-02 D-1815-2015

Class I · High risk Ongoing Jul 13, 2015

Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C…

Reason Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA…

Life and More LLC D-0664-2016

Class I · High risk Ongoing Jul 2, 2015

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

Reason Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

Xtreme Z Distributors INC D-1165-2016

Class II · Moderate risk Ongoing Jun 30, 2015

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL…

Reason Crystallization; identified as calcium salt of Ketorolac

Hospira Inc. NDC 0409-3796-01 D-1242-2015

Class II · Moderate risk Ongoing Jun 30, 2015

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL…

Reason Crystallization; identified as calcium salt of Ketorolac

Hospira Inc. NDC 0409-3795-01 D-1241-2015

Class II · Moderate risk Ongoing May 15, 2014

Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…

Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…

Franck's Lab Inc dba Trinity Care Solutions D-1482-2014