June 2022 recalls

857 recalls were announced in June 2022.

What the numbers show

Critical: 29
Severe: 246
High: 439
Moderate: 141
Low: 2

Of the 857 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

Which agencies issued them

801–857 of 857

HighFDA (Drugs)·D-0919-2022·2022-06-01
Compounded Injectable Drug Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication, due to lack of sterility assurance. The recall affects 528 vials from Lot K24409.
Product
AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0906-2022·2022-06-01
FDA Recalls Sodium Tetradecyl Sulfate Injection Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 0.3% Injection due to lack of sterilization assurance. The 943 vials of this injectable product were distributed nationwide and may not meet sterile manufacturing requirements.
Product
Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0947-2022·2022-06-01
Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling QM-2, a compounded multi-dose injectable medication, because the manufacturer cannot assure the product's sterility. The recall affects 619 vials distributed nationwide.
Product
QM-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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0930-2022·2022-06-01
Lidocaine 2% injectable solution recalled for lack of sterility assurance
Olympia Pharmaceuticals recalled 1195 vials of Lidocaine 2% due to lack of assurance of sterility. The vials were distributed nationwide and should not be used.
Product
Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0904-2022·2022-06-01
Sodium Bicarbonate 8.4% Injectable Recalled Over Sterility Assurance Concerns
Olympia Compounding Pharmacy is recalling 1,466 vials of Sodium Bicarbonate 8.4% Multi-Dose Injectable (Lot L41002) due to lack of assurance of sterility. The product was distributed nationwide.
Product
Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2022·2022-06-01
Medical beds with motorized wheels face uncontrolled motion risk
Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.
Product
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0909-2022·2022-06-01
FDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
Olympia Compounding Pharmacy is recalling T-105 Papaverine injection vials due to lack of assurance of sterility. The recall affects 3,312 vials distributed nationwide.
Product
T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0948-2022·2022-06-01
Compounded injectable medication recalled for sterility assurance failure
Olympia Compounding Pharmacy is recalling QM-3, a multi-dose compounded injectable, due to lack of sterility assurance. The recall includes 414 vials distributed nationwide.
Product
QM-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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1120-2022·2022-06-01
Protekt Sharps Safety Knives with Incorrect Size Label
International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.
Product
Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0907-2022·2022-06-01
FDA Recalls Sodium Tetradecyl Sulfate Injectable Over Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% Injection (480 vials, Lot B24308-22) due to lack of assurance of sterility. The injectable was distributed nationwide.
Product
Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0916-2022·2022-06-01
FDA Recalls Zinc Chloride Injectable Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 1,291 vials of Zinc Chloride injectable nationwide due to lack of assurance of sterility.
Product
Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1131-2022·2022-06-01
Medtronic Cardioblate Gemini-s Surgical Ablation System Recalled for Fractured Jaw Tips
Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.
Product
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0894-2022·2022-06-01
Blood Pressure Medication Recalled for Manufacturing Impurity
Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.
Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1134-2022·2022-06-01
SUR-FIT Natura Durahesive Wafer Recalled for Skin Barrier Delamination
ConvaTec is recalling 600 market units of SUR-FIT Natura S4S Durahesive Wafer due to skin barrier delamination. The wafer's layers or tape borders may fail to maintain proper seal, potentially affecting skin protection.
Product
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0939-2022·2022-06-01
FDA recalls NAD+ pharmaceutical powder vials due to sterility concerns
Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide powder vials nationwide due to lack of assurance of sterility. The recall affects 8,982 vials distributed across the USA, Puerto Rico, and US Virgin Islands.
Product
NAD+ 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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1083-2022·2022-06-01
HEB Bakery Two-Bite Brownies recalled for potential metal fragments
H-E-B Grocery Company recalls HEB Bakery Two-Bite Brownies due to potential metal fragments in the product. Affected packages were distributed in Texas.
Product
HEB Bakery Two-Bite Brownies NET WT 12 OZ (340g) UPC 0471220109517 packaged in plastic clamshell container 24 packages per case
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1122-2022·2022-06-01
Olympus Grasping Forceps FG-51D Recalled for Noncompliance With Force Standards
Olympus Corporation recalled 1,386 units of Disposable Grasping Forceps FG-51D due to noncompliance with force standards for opening and closing the devices.
Product
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1137-2022·2022-06-01
Progenamatrix Human Keratin Matrix Recalled for Inadequate Pouch Seal
ProgenaCare is recalling progenamatrix Human Keratin Matrix due to inadequate inner pouch seals that may compromise sterility. The recall affects 547 packages distributed in Alabama, Georgia, Florida, Tennessee, and Texas.
Product
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0889-2022·2022-06-01
Prescription Drug Daytrana Patches Recalled for Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches from Lot 90764 (expiration 08/2022) distributed nationwide due to defects in the delivery system. The recall was initiated after customer complaints exceeded FDA action limits.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0932-2022·2022-06-01
Lipo-Mino-Mix Injectable Compounded Drug Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lipo-Mino-Mix injectable vitamins nationwide due to manufacturing failure to ensure product sterility. No illnesses have been reported.
Product
Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0922-2022·2022-06-01
Cyanocobalamin Injectable Vials Recalled Due to Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls 1282 vials of Cyanocobalamin 2 mg/mL due to lack of sterility assurance. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Product
Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0115-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0944-2022·2022-06-01
FDA Recalls Olympia Alprostadil 150 mcg/mL Injectable Vials for Sterility Concerns
Olympia Compounding Pharmacy is recalling PGE-3 Alprostadil 150 mcg/mL multi-dose injectable vials nationwide due to lack of assurance of sterility. The recall involves 421 vials from lot L24508.
Product
PGE-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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0928-2022·2022-06-01
Formula F2 Compounded Injectable Medication Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Formula F2, a multi-ingredient injectable medication, because the manufacturer cannot assure sterility. The recall affects 72 vials distributed nationwide.
Product
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1133-2022·2022-06-01
INTERTAN 1.5 nail orthopedic implants recalled due to reversed left-right labeling
Smith & Nephew is recalling INTERTAN 1.5 nails because right nails were marked and labeled as left nails, and vice versa. This mislabeling could lead to incorrect surgical placement.
Product
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0929-2022·2022-06-01
Compounded Injectable Medication Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling 205 vials of Formula F9 injectable medication nationwide due to lack of assurance of sterility. The FDA has classified this as a Class II recall.
Product
Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0913-2022·2022-06-01
Tri-Immune Boost Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 2,260 vials of Tri-Immune Boost injectable supplement due to lack of sterility assurance. Distribution was nationwide, including Puerto Rico and US Virgin Islands.
Product
Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0911-2022·2022-06-01
Testosterone Cypionate Injectable Vials Recalled Due to Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls Testosterone Cypionate injectable vials distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
Product
Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0934-2022·2022-06-01
Injectable drug recalled for lack of sterility assurance
Olympia Compounding Pharmacy is recalling injectable Lipostat Plus SF vials due to inability to assure sterility. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0048-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0937-2022·2022-06-01
MICC Injectable Drug Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 5,334 vials of MICC injectable due to lack of sterility assurance. Distribution was nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0949-2022·2022-06-01
FDA Recalls Amino Blend Injectable Vials Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling Amino Blend injectable vials due to lack of assurance of sterility. Approximately 7,761 vials were distributed nationwide. The FDA has classified this as a Class II recall.
Product
Amino 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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0901-2022·2022-06-01
Olympia Compounding Pharmacy Recalls Papaverine-Phentolamine Injectable Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling SB-6, a compounded injectable medication, due to lack of assurance of sterility. The recall affects 874 vials distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Product
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0924-2022·2022-06-01
Dexpanthenol 250 mg/mL Injectable Solution Recalled for Sterility Failure
Olympia Compounding Pharmacy is recalling 1,296 vials of Dexpanthenol 250 mg/mL injectable solution distributed nationwide due to lack of assurance of sterility in the manufacturing process.
Product
Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0070-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0891-2022·2022-06-01
Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Elevated Azido Impurity
Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.
Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0912-2022·2022-06-01
FDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalled Testosterone Cypionate injection vials due to lack of sterility assurance. The affected lot was distributed nationwide. Patients should contact their healthcare provider immediately.
Product
Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0926-2022·2022-06-01
Injectable Folic Acid and Hydroxocobalamin Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL injectable due to lack of sterility assurance. The affected vials were distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Product
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0940-2022·2022-06-01
Injectable pharmaceutical vial recalled due to sterility assurance failure
Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.
Product
NB-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.
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V391000·2022-06-01
Elgin RegenX Vehicles Recalled for Loose Fan Assembly Bolts
Elgin Sweeper is recalling 2018-2022 RegenX vehicles because improperly tightened fan assembly bolts may detach, creating a road hazard and increasing crash risk.
Product
ELGIN — ELGIN REGENX
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0915-2022·2022-06-01
Vitamin D3 Injectable Recalled Due to Sterility Assurance Issues
Olympia Compounding Pharmacy is recalling Vitamin D3 injectable vials due to lack of sterility assurance. A total of 3,083 vials were distributed nationwide.
Product
Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0075-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0893-2022·2022-06-01
Losartan Potassium and Hydrochlorothiazide Recall: Impurity Levels Above Acceptable Limits
Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.
Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0946-2022·2022-06-01
Pyridoxine Injection Vials Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine HCL 100 mg/mL injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Pyridoxine 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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0936-2022·2022-06-01
Methylcobalamin Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.
Product
Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2022·2022-06-01
Unclearred VerifyNow P2Y12 Platelet Test Variant Distributed to Healthcare Providers
Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.
Product
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2022·2022-06-01
HydroMARK Breast Biopsy Marker Label Mismatch on Patient Documentation
Devicor Medical Products is recalling 90 HydroMARK Breast Biopsy Markers due to mismatched patient labels that incorrectly identify the product model. The small patient label identifies the device as model 4010-05-08-T3, while the correct model is 4010-05-08-T4.
Product
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0885-2022·2022-06-01
Losartan HCTZ Medication Recalled for Elevated AZIDO Impurity
RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.
Product
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1126-2022·2022-06-01
Gibeck Humid-Vent Breathing Filters Recalled for Torn Corrugated Tubes
Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.
Product
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0903-2022·2022-06-01
Pharmaceutical Diluent Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1132-2022·2022-06-01
Surgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity
Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.
Product
Surgical Suture Kit
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0938-2022·2022-06-01
Myers Cocktail Injectable Vials Recalled for Sterility Assurance Issues
Olympia Compounding Pharmacy is recalling Myers Cocktail injectable vials due to lack of assurance of sterility. The recall affects approximately 13,679 vials distributed nationwide.
Product
Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial, Rx Only, Olympia…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1119-2022·2022-06-01
Steris Non-Woven Sponges recalled; product not approved for US distribution
Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.
Product
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1118-2022·2022-06-01
Steris Recalls Ultra Pure Non-Woven Sponges for Unapproved Distribution
Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.
Product
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0890-2022·2022-06-01
Vegan Lip Balm Recalled Due to Active Ingredient Mislabeling
Higher Education Make Out Ready Vegan Lip Balm is recalled due to mislabeling of active ingredients. The label does not match the product's actual sunscreen actives.
Product
Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0896-2022·2022-06-01
Drug Recall: Tivicay Tablets with Incorrect Expiration Date on Label
GlaxoSmithKline is recalling 328 bottles of Tivicay (dolutegravir) tablets nationwide due to incorrect expiration date labeling. The label shows January 2027 but the correct expiration date is September 2026.
Product
TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1123-2022·2022-06-01
Benzphetamine tablets recalled due to label mix-up with Benzonatate
Calvin Scott & Company recalled Benzphetamine 50mg tablets due to a labeling error where bottles labeled as Benzonatate 100mg capsules contained Benzphetamine 50mg tablets and vice versa. One physician in Alpharetta, Georgia received 13 affected bottles.
Product
Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0888-2022·2022-06-01
Zonisamide Capsules USP recalled for quality control system deviation
Direct Rx is recalling Zonisamide Capsules USP 100 mg, lot 23JY2124, nationwide due to gaps in the quality control microbiology laboratory that could affect product verification.
Product
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1082-2022·2022-06-01
Tereos Wheat Gluten Recalled Due to 2-Chloroethanol Traces
Able Sales Company is recalling Tereos Wheat Gluten containing traces of 2-chloroethanol. The affected product was distributed in Puerto Rico.
Product
Tereos Wheat Gluten, Net Weight 50 lbs, Distributed by Meelunie, Produced in France
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1085-2022·2022-06-01
Wegmans Fresh Goat Cheese Recalled for Cheesecloth Contamination
Wegmans Brand Fresh Goat Cheese (Classic Chevre with Cranberries) is being recalled because pieces of cheesecloth may be present on the exterior surface. The product was distributed in New York.
Product
Wegmans Brand Fresh Goat Cheese, Classic Chevre, with Cranberries, 5.5lb; packaged in Cryovac Bags
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-1125-2022·2022-06-01
Medical device labeling error: KWIK-STIK® plus Clostridium perfringens
Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.
Product
KWIK-STIK" plus: Clostridium perfringens
Category
Medical Device
Distribution
Distributed nationwide

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