Class I - Dangerous
Failed Impurities/Degradation Specifications
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class I - Dangerous
Defective Container: Product has incomplete induction seals.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class I - Dangerous
cGMP Deviations: deviations leading to potential cross-contamination.
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class I - Dangerous
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class I - Dangerous
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class I - Dangerous
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Amerisource Health Services
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Lack of Assurance of Sterility
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class I - Dangerous
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets