DrugJun 8, 2022
Losartan Potassium Tablets, USP 25 mg recall — FDA D-0972-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedStrides Pharma Inc.
June 2022 recalls — page 12
These records include useful source details for the selected month.
DrugJun 8, 2022
Nephron Sterile Compounding Center Succinylcholine Chloride Injection, USP, 100 mg/5 mL recall — FDA D-0969-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Phenylephrine HCl Injection, USP, 1 mg/10 mL recall — FDA D-0967-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Losartan Potassium Tablets, USP, 100 mg recall — FDA D-0974-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedStrides Pharma Inc.
DrugJun 8, 2022
Nephron Sterile Compounding Center Phenylephrine HCl Injection, USP, 0.8 mg/10 mL recall — FDA D-0966-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium recall — FDA D-0964-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP recall — FDA D-0954-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) recall — FDA D-0968-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 recall — FDA D-0952-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) recall — FDA D-0961-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Family Dollar Stores, LLC Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat recall — FDA D-0981-2022
cGMP deviations: product stored outside of labeled temperature requirements.
Class IIFDA: OngoingFamily Dollar Stores, LLC.
DrugJun 8, 2022
Nephron Sterile Compounding Center Ketamine Hydrochloride Injection, USP, 30 mg/3 mL recall — FDA D-0959-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Losartan Pot./HCTZ 100/12.5 mg Packaged and recall — FDA D-0971-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedDirect Rx
DrugJun 8, 2022
Family Dollar Stores, LLC Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E recall — FDA D-0979-2022
cGMP deviations: product stored outside of labeled temperature requirements.
Class IIFDA: OngoingFamily Dollar Stores, LLC.
DrugJun 8, 2022
Nephron Sterile Compounding Center 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 recall — FDA D-0950-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Losartan Potassium Tablets, USP, 50 mg recall — FDA D-0973-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedStrides Pharma Inc.
DrugJun 8, 2022
Nephron Sterile Compounding Center Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL) recall — FDA D-0962-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Ketamine Hydrochloride Injection, USP, 50 mg/5 mL recall — FDA D-0960-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) recall — FDA D-0958-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) recall — FDA D-0956-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL recall — FDA D-0963-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Phenylephrine HCl Injection, USP, 0.4 mg/10 mL recall — FDA D-0965-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 recall — FDA D-0953-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugJun 8, 2022
Nephron Sterile Compounding Center Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL recall — FDA D-0951-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.