Drug and pharmaceutical recalls
17728 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-DrugTorrent Pharma IncClass IIChildren's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIRisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugSELECT DISTRIBUTIONS LLCClass IAphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
- 2019-06-19FDA-DrugB. Braun Medical IncClass IIHeparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
- 2019-06-19FDA-DrugChiesi USA, Inc.Class IIZileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Failed Dissolution Specifications: Out of specification result for dissolution.
- 2019-06-19FDA-DrugChiesi USA, Inc.Class IIZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
Failed Dissolution Specifications: Out of specification result for dissolution.
- 2019-06-19FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIEstradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IITrimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL 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 IITestosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IITestosterone Cyp/Pro 95/5%, 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 IITestosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30
Lack of Sterility Assurance.
- 2019-06-19FDA-DrugPharm D Solutions, LLCClass IISermorelin/GHRP-2 &6 (9-9-9 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/GHRP-2 &6 (9-9-9-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/GHRP-2 & 6 (3-3-3 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/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.
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