Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IISermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IISermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IISermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IINandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IILipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IIIpamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IIHuman Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IIHuman Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IIHuman Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IIB-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IIBacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Lack of Sterility Assurance.
- 2019-06-05FDA-DrugStiff Boy LLCClass IThe Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
- 2019-06-05FDA-DrugLupin Pharmaceuticals Inc.Class IICefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
- 2019-06-05FDA-DrugInopak LtdClass IIUnison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIAntibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IISani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIMild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIAntibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIINOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIINODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIInstant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bot
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIAQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugInopak LtdClass IIANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, In
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
- 2019-06-05FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIBevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27
Lack of assurance of sterility
- 2019-05-29FDA-DrugNovartis Pharmaceuticals Corp.Class IPromacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
- 2019-05-29FDA-DrugSeptodont Inc.Class IIArticaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
- 2019-05-29FDA-DrugMALLINCKRODT PHARMACEUTICALSClass IIAmitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
- 2019-05-29FDA-DrugMALLINCKRODT PHARMACEUTICALSClass IIAmitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
- 2019-05-29FDA-DrugHeritage Pharmaceuticals, Inc.Class IILosartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- 2019-05-29FDA-DrugHeritage Pharmaceuticals, Inc.Class IILosartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
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