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.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIGlutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IICefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIRopivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIRopivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIRopivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIFentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIMethylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIMedroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIMagnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIHyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIHyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIGlycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. 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 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIEDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIB-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIAscorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIAscorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugGuardian Pharmacy ServicesClass IIMorphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Lack of sterility assurance.
- 2018-08-15FDA-DrugLongbow First Aid Products ManufactoryClass IIEyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
CGMP Deviations
- 2018-08-15FDA-DrugLongbow First Aid Products ManufactoryClass IIEmergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
CGMP Deviations
- 2018-08-15FDA-DrugRight Value Drug Stores, Inc.Class IIITestosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
- 2018-08-15FDA-DrugAkorn, Inc.Class IILidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
- 2018-08-15FDA-DrugPharMEDium Services, LLCClass II10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- 2018-08-15FDA-DrugPharMEDium Services, LLCClass II5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- 2018-08-15FDA-DrugPharMEDium Services, LLCClass II10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- 2018-08-15FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIPrednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
Defective Container: Tamper Evident foil seal not completely intact.
- 2018-08-15FDA-DrugValeant Pharmaceuticals North America LLCClass IIIDiazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
- 2018-08-15FDA-DrugPharmalucence, Inc.Class IIKit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
- 2018-08-15FDA-DrugNuCare Pharmaceuticals IncClass IIValsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-15FDA-DrugNuCare Pharmaceuticals IncClass IIValsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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