Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 3 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIHydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IICalmme Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIBuckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIBi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIBi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIBi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIZinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIZinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IIVancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 75 mg and B12 6 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone USP (10 AQUEOUS) 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- 2015-09-23FDA-DrugThe Compounding Pharmacy of AmericaClass IITestosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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