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.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIP/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIP/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIAcetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIMedroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIVitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIDehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIMorphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IITriple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIAvastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIDMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIAtropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
- 2018-08-22FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAtorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
- 2018-08-22FDA-DrugThe Hain Celestial Group, Inc. - Worldwide HQClass IIalba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
Microbial Contamination of a Non-Sterile Product
- 2018-08-22FDA-DrugLupin Pharmaceuticals Inc.Class IILisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
- 2018-08-22FDA-DrugHuijing (Shanghai) Bio-tech Co., Ltd.Class IIIAcne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
- 2018-08-15FDA-DrugWorld Organix, LLCClass IBlissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- 2018-08-15FDA-DrugWorld Organix, LLCClass IBlissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- 2018-08-15FDA-DrugWorld Organix, LLCClass IBlissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- 2018-08-15FDA-DrugWorld Organix, LLCClass IBlissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- 2018-08-15FDA-DrugWorld Organix, LLCClass IBlissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- 2018-08-15FDA-DrugMylan Pharmaceuticals Inc.Class IIDymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
- 2018-08-15FDA-DrugTeva Pharmaceuticals USAClass IIOmega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIPhenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIMIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIMethylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIGlutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IILidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
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