May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distribute
Hazard: Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
May 1, 2019DrugsFDA
Akorn Inc recalls Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by:
Hazard: Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suit
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suit
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Ch
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bl
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charl
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlo
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, B
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, B
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 G
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlott
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte,
Hazard: Lack of sterility assurance.
May 1, 2019DrugsFDA
CMC Enterprise Pharmacy recalls Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte,
Hazard: Lack of sterility assurance.