Drug and pharmaceutical recalls

17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugR Thomas Marketing, LLCClass I
Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Marketed Without An Approved NDA/ANDA
2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class I
Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class I
Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class I
Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class I
Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class I
Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
2016-06-01FDA-DrugCentro NaturistaClass I
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
2016-06-01FDA-DrugCentro NaturistaClass I
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
2016-06-01FDA-DrugAkorn, Inc.Class II
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
2016-06-01FDA-DrugAkorn, Inc.Class II
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
2016-06-01FDA-DrugAkorn, Inc.Class II
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
2016-06-01FDA-DrugSanofi-Aventis U.S. LLCClass I
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Defective Delivery System; potential to have inaccurate dosage delivery
2016-06-01FDA-DrugSanofi-Aventis U.S. LLCClass I
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Defective Delivery System; potential to have inaccurate dosage delivery
2016-06-01FDA-DrugPharmakon PharmaceuticalsClass I
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
2016-06-01FDA-DrugPacifico National, Inc. dba AmEx PharmacyClass I
Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Non-Sterility: Product tested positive for bacterial contamination.
2016-06-01FDA-DrugPacifico National, Inc. dba AmEx PharmacyClass I
Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Non-Sterility: Product tested positive for bacterial contamination.
2016-06-01FDA-DrugTeva North AmericaClass II
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454
Lack of Assurance of Sterility: Due to potential for leaking bags.
2016-06-01FDA-DrugFresenius Kabi USA, LLCClass II
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
Failed Impuities/Degradation Specifications
2016-06-01FDA-DrugFresenius Kabi USA, LLCClass II
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
Failed Impuities/Degradation Specifications
2016-06-01FDA-DrugHospira Inc.Class I
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, NDC 0409-6625-02
Presence of Particulate Matter: particulate matter identified as an insect in one vial.

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