Category
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.
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIPhenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIPhenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIOxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IINeostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IILidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IILabetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIKetamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIKetamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIHydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIHydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIGlycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIGlycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIFentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIEpinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IIEPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass IICalcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
Lack of Assurance of Sterility
- 2022-06-08FDA-DrugNephron Sterile Compounding Center LLCClass II8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Lack of Assurance of Sterility
- 2022-06-01FDA-DrugCalvin Scott & Company, Inc.Class IBenzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
- 2022-06-01FDA-DrugCalvin Scott & Company, Inc.Class IIIBenzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIAmino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIQM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0019-10.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIQM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0066-30.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPhenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIOndansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIOlympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIOlympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IINB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10.
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IINAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0083-00.
Lack of assurance of sterility.
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