June 2023 recalls

513 recalls were announced in June 2023.

What the numbers show

Critical: 13
Severe: 183
High: 259
Moderate: 57
Low: 1

Of the 513 recalls this month scored against our rubric, 3% are Critical, 36% are Severe.

Which agencies issued them

401–500 of 513

HighFDA (Drugs)·D-0863-2023·2023-06-07
Ropivacaine Hydrochloride Injection recalled; manufacturer unable to complete stability studies
Akorn, Inc. recalls all lots of Ropivacaine Hydrochloride Injection nationwide because the manufacturer went out of business and cannot complete required stability studies.
Product
Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1657-2023·2023-06-07
QUADROX-i Small Adult Oxygenator Recalled Due to Packaging Sterile Barrier Defect
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Adult Oxygenators used in heart bypass surgery because product packaging may contain tiny pinholes that compromise sterile integrity, potentially allowing non-sterile exposure.
Product
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0812-2023·2023-06-07
FDA Recalls IC-Green Injectable Drug: Manufacturing Deviations Prevent Stability Verification
Akorn, Inc. recalled all lots of IC-Green injectable drug nationwide because the firm went out of business and could not complete stability studies required to verify manufacturing compliance.
Product
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0808-2023·2023-06-07
Guaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Guaifenesin Oral Solution nationwide due to CGMP deviations. The manufacturer ceased operations before completing required stability testing to verify the product's safety and efficacy.
Product
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1653-2023·2023-06-07
Knee replacement implant bearing inserts mislabeled with wrong catalog numbers
Howmedica Osteonics recalled 24 TRIATHLON X3 tibial bearing inserts due to mislabeling, where units labeled with one catalog number may contain a different size. Medical facilities should discontinue use and contact the manufacturer.
Product
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1665-2023·2023-06-07
Elekta Medical Linear Accelerator Component Non-Compliant with Safety Standard
Elekta Inc. is recalling a limited number of Elekta Linacs due to a component non-compliant with safety standards. No reported injuries or illnesses.
Product
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Category
Medical Device
Distribution
7 states
HighFDA (Drugs)·D-0825-2023·2023-06-07
Lorazepam Injection Recalled Due to Manufacturing Control Deviations
Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL due to CGMP deviations. The firm ceased operations and could not continue required stability studies.
Product
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0792-2023·2023-06-07
Ciclopirox Topical Solution Recalled Due to Manufacturing Practice Violations
Ciclopirox 8% topical solution (nail lacquer) is recalled nationwide. The manufacturer went out of business and could not complete required stability testing to ensure product safety.
Product
Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1634-2023·2023-06-07
Cardiopulmonary bypass oxygenator recalled due to sterile barrier packaging defects
Maquet Medical Systems USA is recalling 8,670 HMOD 70000-USA/QUADROX-iD Adult oxygenators used in cardiopulmonary bypass due to packaging defects that may compromise sterile barriers and expose devices to contamination.
Product
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0776-2023·2023-06-07
FDA Recalls Hydromorphone Injections Due to Discontinued Quality Assurance Program
The FDA is recalling Hydromorphone HCl 10 mg injections due to the manufacturer's discontinuation of its quality assurance program. The product, distributed in Missouri, may not meet standards for strength, purity, and identity.
Product
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0859-2023·2023-06-07
Akorn Midazolam Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Midazolam Injection nationwide due to manufacturing practice deviations. The company ceased operations and could not complete stability studies to verify the drug's safety and efficacy.
Product
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0815-2023·2023-06-07
Lactulose Solution Recall Due to Manufacturing Practice Deviations
Akorn, Inc. has recalled all lots of Lactulose Solution, USP 30 mL Unit Dose Cups nationwide due to the company's inability to continue stability studies after ceasing operations.
Product
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0845-2023·2023-06-07
Sodium Chloride Ophthalmic Solution Recalled Due to Incomplete Stability Studies
Akorn Operating Company is recalling all lots of Sodium Chloride Ophthalmic Solution (5%, 50mg/mL) nationwide because the firm went out of business and could not complete required stability studies to verify product safety and effectiveness.
Product
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1644-2023·2023-06-07
EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings
Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.
Product
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0832-2023·2023-06-07
FDA Recalls All Olopatadine HCl Nasal Spray Lots Due to Manufacturing Deviations
The FDA is recalling all lots of Olopatadine HCl Nasal Spray (665 mcg, manufactured by Akorn) nationwide and in Puerto Rico due to manufacturing quality deviations and incomplete stability studies.
Product
Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1627-2023·2023-06-07
Medical X-Ray Imaging System Recalled for Device Malfunction
The CS 9600 X-ray imaging system manufactured by Trophy SAS has been recalled worldwide due to failure to function as intended and non-conformance to design specifications. Approximately 895 units are affected.
Product
CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿a…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1668-2023·2023-06-07
Medical Device Recall: X-Ray Detector Drive Shaft May Break
The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.
Product
Intelli-C, Right side suspended Tabletop, REF: 03400000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0772-2023·2023-06-07
Cough medicine recalled due to manufacturing process deviation with non-food lubricant
Denison Pharmaceuticals is recalling Safe tussin DM DAY TIME Cough Relief due to use of non-food grade lubricant in the manufacturing process. Approximately 86,616 bottles were distributed nationwide.
Product
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0958-2023·2023-06-07
Fresh location Apple Cranberry Walnut Salad recalled for potential metal contamination
The H.T. Hackney Company is recalling Fresh location Apple Cranberry Walnut Salad in 7.5 oz containers due to potential metal contamination. Consumers should not consume this product.
Product
Fresh location Apple Cranberry Walnut Salad, 7.5oz clear plastic container, UPC 8 55110 00815 2
Category
Food
Distribution
4 states
HighFDA (Drugs)·D-0818-2023·2023-06-07
Levofloxacin Injection Nationwide Recall Due to Manufacturing Deviations
Akorn, Inc. has recalled all lots of Levofloxacin Injection nationwide due to manufacturing process violations and inability to complete required stability studies.
Product
Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0809-2023·2023-06-07
HydrALAZINE Injection Recalled Due to Manufacturing Deviations and Unverified Stability
Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection nationwide because the manufacturer ceased operations and could no longer conduct required stability studies.
Product
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0843-2023·2023-06-07
Fentanyl Citrate Injection Nationwide Recall Due to Manufacturing Compliance Deviations
Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.
Product
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1669-2023·2023-06-07
X-Ray Machine Detector May Move Unexpectedly Due to Drive Shaft Failure
FDA recalls the Intelli-C X-Ray machine's left side suspended tabletop model due to potential drive shaft failure in the detector lift mechanism, which could cause uncontrolled detector movement.
Product
Intelli-C, Left side suspended Tabletop, REF: 03400010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0836-2023·2023-06-07
Prednisolone Oral Solution Recalled Due to Manufacturing Standards Deviation
Akorn, Inc. is recalling all lots of Prednisolone Oral Solution 15 mg/5 mL due to a manufacturing standards deviation. The company discontinued required stability studies after ceasing operations.
Product
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0790-2023·2023-06-07
FDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA is recalling all lots of Calcitriol Injection 1 mcg/mL due to current good manufacturing practice (CGMP) violations. The manufacturer went out of business and could not complete required stability studies.
Product
Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0826-2023·2023-06-07
Lorazepam Oral Concentrate Recalled Due to Manufacturing Practice Deviations
Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate (2 mg/mL) due to Current Good Manufacturing Practice deviations. The manufacturer went out of business and could not complete required stability studies.
Product
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0785-2023·2023-06-07
Artificial Tears Solution Recalled Due to CGMP Deviations and Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) nationwide due to CGMP compliance issues and inability to complete required stability studies after the firm went out of business.
Product
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0807-2023·2023-06-07
Akorn Guaiatussin AC Sugar-Free Cough Suppressant Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free nationwide due to manufacturing deviations. The firm went out of business and could not continue stability studies.
Product
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0802-2023·2023-06-07
Ephedrine Sulfate Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection due to manufacturing compliance deviations; the firm was unable to complete required stability studies.
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1654-2023·2023-06-07
Knee Replacement Insert Mislabeled; Contents May Not Match Catalog Number
Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during surgery.
Product
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0780-2023·2023-06-07
Acetaminophen & Codeine Oral Solution Recalled Due to Unverified Stability
Akorn, Inc. is recalling all lots of Acetaminophen & Codeine Oral Solution because stability studies cannot be completed. The firm ceased operations and cannot verify the medication's potency and safety.
Product
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0820-2023·2023-06-07
Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations
Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.
Product
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2023·2023-06-07
Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier
Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.
Product
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1673-2023·2023-06-07
Smith & Nephew ENGAGE Knee System Recalled for Elevated Revision Risk
Smith & Nephew's ENGAGE Cementless Partial Knee System is being recalled due to higher-than-expected revision rates compared to similar devices. The recall affects 7,531 units distributed nationwide.
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0830-2023·2023-06-07
Naloxone Injection Recall Due to Manufacturing Process Deviations
Akorn, Inc. is recalling all lots of Naloxone Injection 0.4 mg/mL due to manufacturing process deviations. The manufacturer could not complete required stability studies.
Product
Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0837-2023·2023-06-07
Promethazine HCl & Codeine Phosphate Oral Solution Recalled Due to Manufacturing Compliance Deviations
Akorn Inc. is recalling all lots of Promethazine HCl & Codeine Phosphate Oral Solution nationwide because the firm went out of business and cannot complete required stability studies.
Product
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0773-2023·2023-06-07
Colic Calm Homeopathic Medicine Recalled for Manufacturing Contamination
Denison Pharmaceuticals is recalling Colic Calm, a homeopathic medicine, due to non-food grade lubricant used in the mixing vessel during manufacturing. Affected lot 8290V was distributed nationwide.
Product
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0839-2023·2023-06-07
Proparacaine HCl Ophthalmic Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution 0.5% due to manufacturing deviations. The manufacturer could not complete required stability studies before going out of business.
Product
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0775-2023·2023-06-07
Cough Relief Medication Recalled for Non-Food Grade Lubricant Manufacturing Defect
Denison Pharmaceuticals is recalling Safe tussin PM nighttime cough relief due to use of non-food grade lubricant during manufacturing. Consumers should stop use and consult a pharmacist.
Product
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0841-2023·2023-06-07
Rifampin Capsules Recall: Incomplete Stability Studies Due to Manufacturer Closure
Akorn Inc. is recalling all lots of Rifampin Capsules USP 300 mg distributed nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required testing.
Product
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1640-2023·2023-06-07
QUADROX-i Neonatal oxygenator recalled for compromised sterile packaging
Maquet Medical Systems is recalling QUADROX-i Neonatal oxygenators due to packaging defects that may compromise sterility. Improper accessory placement and packaging damage could expose the device to contamination, risking infection and sepsis.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0862-2023·2023-06-07
Pilocarpine Hydrochloride Ophthalmic Solution Recalled for Manufacturing Compliance Deviations
The FDA has recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 4% due to manufacturing process deviations. The distributor ceased operations and cannot complete required stability testing.
Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2023·2023-06-07
QUADROX-i Pediatric Oxygenator Packaging Defects Compromise Sterile Barrier
FDA Class II recall of QUADROX-i Pediatric oxygenators due to packaging defects—creases, holes, cracks—that compromise sterile barriers, risking infection and sepsis during cardiopulmonary bypass procedures.
Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects
Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1637-2023·2023-06-07
QUADROX-i Small Adult Oxygenator Recall Due to Sterile Packaging Defects
Maquet is recalling QUADROX-i Small Adult Oxygenators due to packaging defects that may compromise the sterile barrier. Exposure to non-sterile product could cause infection, sepsis, and ischemia.
Product
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0777-2023·2023-06-07
Sodium Chloride Injection Recalled Due to Storage Temperature Exposure Risk
Fresenius Medical Care is recalling Sodium Chloride 0.9% Injection due to potential storage temperature exposure that may compromise sterility. The affected product includes 53,424 bags distributed to clinics in South Carolina, North Carolina, and Virginia.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0840-2023·2023-06-07
Rifampin Capsules Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg distributed nationwide due to manufacturing deviations. The company ceased business before completing required stability studies to verify the drug remains safe and effective throughout its shelf life.
Product
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1635-2023·2023-06-07
Oxygenator devices recalled due to packaging damage compromising sterile barrier
Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.
Product
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0849-2023·2023-06-07
Timolol Maleate Ophthalmic Solution Recalled for Manufacturing and Stability Testing Defects
Akorn, Inc. has recalled all lots of Timolol Maleate Ophthalmic Solution 0.5% nationwide due to manufacturing quality deviations and inability to complete stability studies.
Product
Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0816-2023·2023-06-07
Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing
Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.
Product
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1671-2023·2023-06-07
Smith & Nephew Knee Prosthesis Recalled Due to Higher-Than-Expected Revision Rate
Smith & Nephew is recalling 1,596 units of its ENGAGE Cementless Partial Knee System due to complaint data indicating higher revision rates than comparable devices. Patients should consult their surgeon.
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0838-2023·2023-06-07
Promethazine HCl Oral Solution Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Promethazine HCl Oral Solution, USP, due to Current Good Manufacturing Practice deviations. The firm went out of business and cannot complete required stability studies.
Product
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1648-2023·2023-06-07
Cytrellis ellacor Dermal Micro-Coring System Recalled for Potential Scarring
Cytrellis Biosystems is recalling 89 units of the ellacor System Gen 4 nationwide due to irregular core patterns that may cause prolonged healing, skin texture irregularities, or scarring.
Product
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0797-2023·2023-06-07
Akorn Recalls Cromolyn Sodium Ophthalmic Solution Over Stability Studies
Akorn Inc. is recalling all lots of Cromolyn Sodium Ophthalmic Solution, USP 4% due to manufacturing deviations. The firm went out of business and could no longer continue required stability studies.
Product
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0829-2023·2023-06-07
Moxifloxacin HCl Ophthalmic Solution Recalled Due to CGMP Compliance Deviation
Moxifloxacin HCl Ophthalmic Solution 0.5% is being recalled because manufacturer Akorn, Inc. ceased operations and cannot complete required stability studies. All lots distributed nationwide in the USA and Puerto Rico are affected.
Product
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0788-2023·2023-06-07
AK-POLY-BAC Ophthalmic Ointment Recall for Manufacturing Compliance Deviations
Akorn, Inc. recalls all lots of AK-POLY-BAC ophthalmic ointment nationwide because the company ceased operations and could not complete required stability testing.
Product
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0787-2023·2023-06-07
Azelastine Hydrochloride Nasal Spray Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Azelastine Hydrochloride Nasal Spray nationwide due to manufacturing process deviations. The firm ceased operations and could no longer conduct required stability studies.
Product
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0817-2023·2023-06-07
Levocarnitine Oral Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. has recalled all lots of Levocarnitine Oral Solution, USP (118 mL bottles) because the company ceased operations and could not complete required stability studies due to CGMP deviations.
Product
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0821-2023·2023-06-07
Lidocaine-Prilocaine Cream Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Lidocaine 2.5% & Prilocaine 2.5% Cream due to CGMP deviations. The manufacturer went out of business and could not complete required stability studies to verify product integrity.
Product
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0799-2023·2023-06-07
Dicyclomine Hydrochloride Injectable Drug Recalled for Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP nationwide due to Current Good Manufacturing Practice deviations. The firm went out of business and could not complete required stability studies.
Product
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0855-2023·2023-06-07
Vitamin D Supplement Drops Recalled Due to Manufacturing Practice Violations
Akorn, Inc. is recalling Vitamin D Supplement Drops (400 IU, Cherry Flavored, 50mL) distributed nationwide because the firm ceased operations and could not complete required stability studies.
Product
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0848-2023·2023-06-07
Akorn Antibiotic Suspension Recalled Due to CGMP Deviations and Unverified Stability
Akorn recalls all lots of Sulfamethoxazole & Trimethoprim Oral Suspension (200mg/40mg per 5mL) nationwide due to inability to complete required stability studies after the company ceased operations.
Product
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0864-2023·2023-06-07
Tropicamide Ophthalmic Solution Recalled by Akorn for CGMP Deviations
Akorn Operating Company is recalling all lots of Tropicamide Ophthalmic Solution 0.1% nationwide due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and could not complete required stability studies.
Product
Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0819-2023·2023-06-07
Levofloxacin Oral Solution Recalled Due to Manufacturing Compliance Issues
Akorn, Inc. recalled all lots of Levofloxacin Oral Solution due to the company going out of business and being unable to continue required stability studies. Patients currently taking this medication should contact their healthcare provider.
Product
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0813-2023·2023-06-07
Akorn Ketorolac Eye Drops Recalled Due to Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5% because the manufacturer went out of business and cannot complete required stability testing.
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0856-2023·2023-06-07
XOPENEX Inhalation Solution Recalled Due to Manufacturing Compliance Issues
Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) inhalation solution because the company went out of business and cannot continue required stability studies. The firm's manufacturing deviations affect product safety verification.
Product
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0801-2023·2023-06-07
Docusate Liquid Drug Recalled Over Incomplete Stability Testing
Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.
Product
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0793-2023·2023-06-07
Cimetidine HCl Oral Solution Recalled Due to Manufacturing Compliance Deviations
Akorn, Inc. is recalling all lots of Cimetidine HCl Oral Solution 300mg/5mL nationwide due to CGMP deviations. The firm ceased operations and could not complete required stability studies.
Product
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1664-2023·2023-06-07
VITROS Chemistry Calibrator Kit Cannot Calibrate Vancomycin Reagent
Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.
Product
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0968-2023·2023-06-07
Magnesium Citrate Dietary Ingredient Recalled for Excess Yeast and Mold
Jost Chemical is recalling magnesium citrate dietary ingredient due to yeast and mold levels exceeding specifications. Approximately 73 drums totaling 8,030 pounds distributed to manufacturers in California and Georgia were affected.
Product
Jost Chemical Magnesium Citrate Tribasic Hydrate, USP, Powder, Net Wt 110 lb/ 50 kg packaged in bulk lined fiber drums
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-0783-2023·2023-06-07
Albuterol Sulfate Syrup Recalled for Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Albuterol Sulfate Syrup nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies to verify ongoing product safety and effectiveness.
Product
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0833-2023·2023-06-07
Olopatadine HCl Eye Drops Recalled for Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1% eye drops due to Current Good Manufacturing Practice deviations. The manufacturer discontinued required stability studies after ceasing operations.
Product
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0822-2023·2023-06-07
Lidocaine Ointment USP Recalled Due to Manufacturing Process Deviations
Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.
Product
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0824-2023·2023-06-07
Akorn Lidocaine Oral Solution Recalled Due to Manufacturing Compliance Deviations
Akorn Operating Company is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution 2% distributed nationally because the firm ceased operations and could not complete required stability studies.
Product
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0842-2023·2023-06-07
Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.
Product
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0779-2023·2023-06-07
Akorn Atropine Sulfate Eye Drops Recalled Due to Manufacturing Compliance Failures
Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% because the firm went out of business and could not complete required stability studies. The product was distributed nationwide in the USA and Puerto Rico.
Product
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0778-2023·2023-06-07
Compounded Phenylephrine Solution Recalled Due to Wrong Base Diluent
Advanced Compounding Solutions is recalling a compounded phenylephrine solution made with 5% Dextrose instead of the correct 0.9% Sodium Chloride diluent. The error affects 198 units distributed nationwide.
Product
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0806-2023·2023-06-07
FDA Recalls Granisetron HCl Injectable Drug Due to Manufacturing Compliance Failure
Akorn, Inc. recalls all lots of Granisetron HCl Injection nationwide because the manufacturer ceased operations and cannot complete required stability studies, leaving the drug's shelf-life unverified.
Product
Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0781-2023·2023-06-07
Acetic Acid Otic Solution recalled due to manufacturing deviations and unverified stability
Akorn is recalling all lots of Acetic Acid Otic Solution nationwide due to manufacturing practice deviations. The firm went out of business and could not complete stability studies required to verify the product remained safe and effective.
Product
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0791-2023·2023-06-07
Cetrorelix Acetate Injectable Recalled Due to Manufacturing Deviations
Akorn, Inc. recalls all lots of Cetrorelix Acetate for Injection due to manufacturing process deviations. The company went out of business and could not complete required stability testing.
Product
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0803-2023·2023-06-07
Ferrous Sulfate Iron Supplement Drops Recalled for Manufacturing Stability Issues
All lots of Ferrous Sulfate Iron Supplement Drops are being recalled nationwide. The manufacturer went out of business and cannot complete required stability studies to verify product safety.
Product
Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0782-2023·2023-06-07
Acyclovir Oral Suspension Recalled for Manufacturing Practice Deviations
Akorn's Acyclovir Oral Suspension is being recalled nationwide due to manufacturing practice deviations. The firm closed and could not complete required stability studies for the medication.
Product
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0794-2023·2023-06-07
Clobetasol Propionate Cream Recalled Due to CGMP Violations and Unverified Stability
Akorn, Inc. is recalling all lots of Clobetasol Propionate Cream 0.05% nationwide because the manufacturer went out of business before completing required stability studies to verify product safety and efficacy.
Product
Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0796-2023·2023-06-07
Clobetasol Propionate Shampoo Recall Due to Manufacturing Compliance Issues
Akorn, Inc. is recalling all lots of Clobetasol Propionate Shampoo, 0.05% distributed nationwide after the firm closed and could not continue required stability studies.
Product
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0844-2023·2023-06-07
Akorn Sodium Chloride Ophthalmic Ointment Recalled Due to Manufacturing Deviations
Akorn Inc. is recalling all lots of Sodium Chloride Ophthalmic Ointment 5% nationwide due to manufacturing practice deviations. The company ceased operations and could not continue stability studies required to verify the product's safety and effectiveness.
Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0850-2023·2023-06-07
Tobramycin Inhalation Solution Recalled Due to Incomplete Stability Studies
All lots of Tobramycin Inhalation Solution manufactured by Akorn, Inc. have been recalled nationwide due to CGMP deviations. The manufacturer was unable to complete required stability studies before ceasing operations.
Product
Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·23V408000·2023-06-06
L'AIR Travel Trailer Recall for Potential Gas Leak Fire Risk
Imagine Fiberglass Products is recalling 2021-2023 L'AIR travel trailers because aluminum burner tubes may fracture, causing a gas leak that could lead to fire.
Product
L'AIR CAMPER — L'AIR CAMPER LION 4500, TRILLIUM HERITAGE 1300, TRILLIUM HERITAGE 4500, LION 1300
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V345000·2023-06-06
Mitsubishi Outlander PHEV backup camera display failure recall
Mitsubishi is recalling certain 2023 Outlander PHEV vehicles due to a software error in the in-vehicle infotainment system that prevents the backup camera image from displaying. This can reduce rear visibility, increasing the risk of a crash or injury.
Product
MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER PHEV
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V407000·2023-06-06
Pierce Aerial Ladder Platform Stabilizer Beam Cracks Pose Instability Risk
Pierce is recalling certain 2016-2022 Ascendant 107' and 110' Platforms with potentially cracked galvanized stabilizer beams that could cause instability when elevated, increasing injury risk.
Product
PIERCE — PIERCE LADDER AND PLATFORM
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V405000·2023-06-05
Mercedes-Benz Recalls EQS and EQE Models for Drivetrain Software Error
Mercedes-Benz is recalling 8,281 electric vehicles due to a software error that may cause a loss of drive power, increasing crash risk.
Product
MERCEDES-BENZ — MERCEDES-BENZ AMG EQS, AMG EQE, EQS 580, EQS 450
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V406000·2023-06-05
2022-2023 Tiffin motorhomes recalled for loss of chassis power
Certain 2022-2023 Tiffin motorhomes built on PowerGlide chassis are recalled because a fuse can trip during air conditioning compressor failure, causing loss of power to the chassis and risking engine stall.
Product
TIFFIN — TIFFIN ALLEGRO BUS, ZEPHYR, PHAETON
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V404000·2023-06-05
2023 Jayco Swift and Entegra Ethos solar panels may detach, creating road hazard
Jayco is recalling 2023 Swift and Entegra Ethos RVs where solar panels may detach from the roof and become road hazards, increasing crash risk. Dealers will install replacement brackets.
Product
ENTEGRA — ENTEGRA, JAYCO ETHOS, ETHOS LI, SWIFT LI, SWIFT
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V401000·2023-06-04
Volvo Recalls 2019-2023 VNR Electric Trucks for Fire Risk
Volvo Trucks North America is recalling 2019-2023 VNR Electric vehicles because loose power cable connections to the windscreen heater relay may cause a fire.
Product
VOLVO — VOLVO VNRE (ELECTRIC)
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·021-2023·2023-06-04
J.T.M. Provisions Recalls Frozen Beef Chili Due To Plastic Contamination
J.T.M. Provisions is recalling approximately 22,530 pounds of frozen beef chili with beans due to possible white plastic contamination. The products were distributed to schools in six states.
Product
J T M Provisions Company — J.T.M. Provisions Company Recalls Frozen Ready-To-Eat Beef Chili Products Due To Possible Foreign Matter Contamination
Category
Food
Distribution
6 states
HighNHTSA·23V403000·2023-06-04
2022-2024 Volvo VNL and VHD trucks: side airbag circuit defect
Volvo is recalling 2022-2024 VNL and VHD trucks with RollTek driver seats due to a missing circuit that prevents side airbag deployment during a crash, increasing injury risk. Dealers will install a jumper harness for free.
Product
VOLVO — VOLVO VNL, VHD
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V402000·2023-06-04
Mack Recalls 2019-2023 LRBE Electric Trucks for Fire Risk
Mack is recalling 2019-2023 LRBE electric trucks because loose power cable connections to the windscreen heater relay may cause overheating and increase the risk of a fire.
Product
MACK — MACK LRBE (ELECTRIC)
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V396000·2023-06-02
Terex Recalls 2021 TL48 Trucks Due to Subframe Weld Defect
Terex is recalling 2021 TL48 trucks because a subframe weld defect could cause the aerial device to fall, increasing injury risk.
Product
TEREX — TEREX TL
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·020-2023·2023-06-02
DEKA Trading Recalls Ineligible Ready-to-Eat Pork Rind Products from Guatemala
DEKA Trading Corp. is recalling ready-to-eat pork rind products imported from Guatemala because the country is ineligible to export meat to the U.S.
Product
DEKA Trading Corp. Recalls Ineligible Ready-To-Eat Pork Rind Products Imported from Guatemala
Category
Food
Distribution
5 states
HighNHTSA·23V399000·2023-06-02
Triple E Recalls 2023 Motorhomes Due to Exposed Wiring Fire Risk
Triple E is recalling 2023 Unity and Wonder motorhomes because a cut air conditioning cable may expose wires to a metal junction box, creating a fire hazard.
Product
TRIPLE E RV — TRIPLE E RV, TRIPLE E WONDER, UNITY
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V400000·2023-06-02
Commercial trucks: park brake warning light may illuminate incorrectly
Autocar commercial trucks from 2016-2023 may have a faulty pressure switch causing the park brake warning light to malfunction, increasing crash risk. Dealers will replace the pressure switch at no cost.
Product
AUTOCAR — AUTOCAR LEGEND, XPEDITOR
Category
Vehicle
Distribution
Distributed nationwide

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