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.
Monthly breakdown
2022 recalls by month
Select a month to review the recall records reported during that period.
December 2022318 records · 4 categoriesNovember 2022270 records · 4 categoriesOctober 2022288 records · 4 categoriesSeptember 2022318 records · 4 categoriesAugust 2022293 records · 4 categoriesJuly 2022334 records · 4 categoriesJune 2022348 records · 4 categoriesMay 2022227 records · 4 categoriesApril 2022205 records · 4 categoriesMarch 2022449 records · 4 categoriesFebruary 2022237 records · 4 categoriesJanuary 2022296 records · 4 categories
2022 recalls — page 88
Records are ordered by the best available source date.
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
Medical DeviceJun 1, 2022
MEDLINE INDUSTRIES, LP - Northfield ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 recall — FDA Z-1140-2022
Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent…
Class IIFDA: TerminatedMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceJun 1, 2022
TELEFLEX MEDICAL (1) Teleflex Flex tube, Product #20011, sterile recall — FDA Z-1127-2022
Reports received of torn corrugated breathing tubes.
Class IIFDA: OngoingTELEFLEX MEDICAL Inc.
Medical DeviceJun 1, 2022
Accriva Diagnostics The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor recall — FDA Z-1121-2022
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was…
Class IIFDA: TerminatedAccriva Diagnostics, Inc.
About the 2022 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.