August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 El
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 1
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook D
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook D
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook D
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 10
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services,
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook D
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elm
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbroo
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elm
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Guardian Pharmacy Services recalls Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elm
Hazard: Lack of sterility assurance.
August 15, 2018DrugsFDA
Longbow First Aid Products Manufactory recalls Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-32
Hazard: CGMP Deviations
August 15, 2018DrugsFDA
Longbow First Aid Products Manufactory recalls Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20
Hazard: CGMP Deviations
August 15, 2018DrugsFDA
Right Value Drug Stores, Inc. recalls Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
August 15, 2018DrugsFDA
Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,
Hazard: Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
August 15, 2018DrugsFDA
PharMEDium Services, LLC recalls 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
Hazard: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
August 15, 2018DrugsFDA
PharMEDium Services, LLC recalls 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDi
Hazard: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
August 15, 2018DrugsFDA
PharMEDium Services, LLC recalls 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fenta
Hazard: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
August 15, 2018DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grov
Hazard: Defective Container: Tamper Evident foil seal not completely intact.
August 15, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.