March 2023 recalls

1,013 recalls were announced in March 2023.

What the numbers show

Critical: 68
Severe: 446
High: 386
Moderate: 107
Low: 6

Of the 1,013 recalls this month scored against our rubric, 7% are Critical, 44% are Severe.

Which agencies issued them

801–900 of 1013

HighFDA (Devices)·Z-1173-2023·2023-03-08
Surgical Sutures Recalled Due to Sterile Barrier Breach Risk in Ophthalmic Procedures
Covidien LP is recalling 12,732 units of surgical sutures (nylon and silk, McKesson brand) due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss when used in eye surgery procedures.
Product
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0388-2023·2023-03-08
Doxazosin tablets recalled due to manufacturing quality control deviations
Accord Healthcare is recalling 75,190 bottles of Doxazosin 4 mg tablets due to manufacturing quality control deviations discovered during an FDA inspection. No illnesses have been reported.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0429-2023·2023-03-08
FDA Recalls Ropinirole 3mg Tablets due to CGMP Deviations
Accord Healthcare's Ropinirole 3mg tablets are being recalled due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 14,928 bottles distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1175-2023·2023-03-08
Novafil Sutures Recalled for Sterile Barrier Breach Risk
Covidien is recalling 48,492 units of Novafil Monofilament Polybutester Sutures due to a sterile barrier breach in the breather pouch that may increase the risk of infection or vision loss during ophthalmic procedures.
Product
Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0394-2023·2023-03-08
Drizzilicious Mini Rice Cake Bites Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites due to undeclared peanut residue that may be present. Consumers with peanut allergies are at risk.
Product
Drizzilicious Mini Rice Cake bites Net Wt. 4oz and/or .74oz Bags Cookies & Cream UPC: 857900005167 and 857900005181 Packaged in a plastic bags Product also packed in the Drizzilicious mini rice cakes 32-ct Variety box
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-1179-2023·2023-03-08
Surgipro Monofilament Polypropylene Sutures Recalled for Sterile Barrier Breach
Surgipro Monofilament Polypropylene Sutures are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Product
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0382-2023·2023-03-08
Winter Mint Chocolate Premier Protein Shake Recalled for Processing Defect
Niagara Bottling is recalling Limited Edition Winter Mint Chocolate Premier Protein Shake 11.5oz because the product did not meet pre-kill step processing specifications and may become spoiled.
Product
Limited Edition Winter Mint Chocolate Premier Protein 30g Protein High Protein Shake 11.5oz (340mL) UPC 00643843801498 packaged in plastic bottles in full wrap lithographpacked in a cardboard case, 12 packages per case
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1170-2023·2023-03-08
Bone fixation plates recalled due to product packaging mix-up
Wright Medical Technology is recalling ORTHOLOC 3DSi CLAW II bone fixation plates due to packaging mix-up in specific lots. Packages contained incorrect product codes.
Product
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2023·2023-03-08
FDA Recalls Rosuvastatin Tablets Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Rosuvastatin 20 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations. The deviations could affect product quality and safety.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1200-2023·2023-03-08
CustomEyes kits recalled due to potential sterility compromise
Beaver Visitec International is recalling 4640 units of CustomEyes kits because packaging may contain open seals that could compromise product sterility. Affected units were distributed to 26 U.S. states and internationally.
Product
CustomEyes kits
Category
Medical Device
Distribution
27 states
HighNHTSA·23V153000·2023-03-08
2023 International MV and HV Vehicles Recalled for Driveshaft Separation Risk
Navistar is recalling certain 2023 International HV and 2023-2024 International MV vehicles due to incorrectly installed rear axle wedge shims that can cause driveshaft separation and loss of drive power. This increases the risk of a crash.
Product
INTERNATIONAL — INTERNATIONAL MV, HV
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0408-2023·2023-03-08
Prescription Drug Simvastatin Recalled for Manufacturing Deviations
Accord Healthcare is recalling Simvastatin 5 mg tablets distributed in the United States, Puerto Rico, and Canada. The recall follows an FDA inspection that identified manufacturing practice deviations.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0423-2023·2023-03-08
FDA Recalls Pravastatin Sodium Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 bottles distributed in the United States, Puerto Rico, and Canada.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0362-2023·2023-03-08
Phenylephrine injection recalled due to lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.
Product
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2023·2023-03-08
Med-Riser MR600 Patient Lift Boom Pivot Failure Risk Recall
Med-Mizer, Inc. is recalling the Med-Riser MR600 Patient Lift due to risk that the boom pivot may fail if the securing nut loosens and the bolt becomes unsecured. Contact the manufacturer for instructions.
Product
Med-Riser MR600 Patient Lift
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0393-2023·2023-03-08
Drizzilicious Mini Rice Cake Bites Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites Cinnamon Swirl due to potential undeclared peanut residue. Individuals with peanut allergies should not consume this product.
Product
Drizzilicious Mini Rice Cake bites Net Wt.4oz and or .74oz Bags Cinnamon Swirl UPC: 857900005167 and UPC:857900005181 Packaged in a plastic bags Product also packed in the Drizzilicious mini rice cakes 32-ct Variety box
Category
Food
Distribution
10 states
HighFDA (Drugs)·D-0361-2023·2023-03-08
Phenylephrine HCl Injection Recalled for Sterility Assurance Deficiency
Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0364-2023·2023-03-08
Sterile Water for Injection Recalled Due to Manufacturing Quality Deviations
Nephron Sc Inc recalls 325,080 vials of Sterile Water for Injection due to manufacturing quality deviations that could result in product carryover. Affected lots expire December 31, 2023.
Product
STERILE WATER — STERILE WATER (STERILE WATER)
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1192-2023·2023-03-08
Alaris PC Unit 8015 wireless network connectivity failure affecting infusion pump management
Certain Alaris PC Unit 8015 infusion pump computers with specific wireless network cards may lose network connectivity, preventing remote infusion programming and data transfer. Manual programming of infusions may be required.
Product
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Category
Medical Device
Distribution
50 states
HighFDA (Drugs)·D-0365-2023·2023-03-08
Aripiprazole tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling 747,464 bottles of Aripiprazole 2mg tablets due to manufacturing process deviations discovered during an FDA inspection. The affected medication was distributed in the United States, Puerto Rico, and Canada.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0373-2023·2023-03-08
Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling 147,736 bottles of Atorvastatin Calcium 40 mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
1 state
HighFDA (Food)·F-0386-2023·2023-03-08
Lobster Ball Product Recalled for Incomplete Shellfish Allergen Labeling
Lobster Ball frozen seafood is recalled for inadequate shellfish allergen labeling. The product contains shellfish but is labeled as 'may contain shellfish,' failing to properly warn consumers with shellfish allergies.
Product
Lobster Ball***Ingredients: Surimi; Nemipterus Spp. (contain Egg), Palm Shortening, Water, Acetylated Tapioca Starch (E1420), Cellulose (E460(i)), Soy Protein, Flying Fish Roe, Permitted Flavour Enhancer***Salt, Sugar, Milk Powder, Emulsifiers, Flavouring***
Category
Food
Distribution
1 state
HighFDA (Food)·F-0399-2023·2023-03-08
Snack Day Vanilla Kettle Corn Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling 1,660 cases of Snack Day by Lidl Vanilla Flavored Kettle Corn due to potential undeclared peanut residue. The product was distributed to retailers in 10 U.S. states.
Product
Snack Day by Lidl Vanilla Flavored Kettle Corn Drizzled with Rainbow Sprinkles Net Wt. 5 oz (141g) Packaged in a plastic bags.
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-1180-2023·2023-03-08
Surgipro II Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.
Product
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0372-2023·2023-03-08
Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were distributed in the United States, Puerto Rico, and Canada.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1197-2023·2023-03-08
Contact Lenses Recalled for Misaligned Axis Causing Poor Vision
CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.
Product
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0366-2023·2023-03-08
Accord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling approximately 1.1 million bottles of Aripiprazole 5mg tablets due to Good Manufacturing Practice deviations identified during an FDA inspection. No illnesses or injuries have been reported.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1194-2023·2023-03-08
Vascular diagnostic devices recalled due to air embolism misconnection risk
Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.
Product
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2023·2023-03-08
Phenylephrine Hydrochloride Injection recalled due to manufacturing practice deviations
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing practice deviations discovered during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
Product
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1195-2023·2023-03-08
Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection
Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.
Product
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1201-2023·2023-03-08
Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.
Product
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0397-2023·2023-03-08
Prescription Glycopyrrolate Injection Recalled Due to Manufacturing Process Deviations
Accord Healthcare is recalling Glycopyrrolate Injection due to manufacturing process deviations found during FDA inspection. The recall involves 5,273 vials distributed across the United States, Puerto Rico, and Canada.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0415-2023·2023-03-08
FDA Recalls Tadalafil Tablets Due to Manufacturing Practice Deviations
Accord Healthcare's Tadalafil 5 mg tablets are being recalled due to deviations from current good manufacturing practices identified during an FDA inspection. Approximately 1,113,264 bottles were distributed across the United States, Puerto Rico, and Canada.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
1 state
HighFDA (Food)·F-0387-2023·2023-03-08
Peanut Butter Hot Chocolate Recalled Due to Undeclared Peanut Allergen
Corim Industries is recalling Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products in multiple formats due to an undeclared peanut allergen. Consumers with peanut allergies should not consume these products.
Product
Cocoa de Aroma, 24 ct single serve coffee pods assorted (12.7 oz carton containing Peanut Butter flavor 0.52 oz. single serve coffee pods)
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1181-2023·2023-03-08
Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach
Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of infection or vision loss during ophthalmic procedures.
Product
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0379-2023·2023-03-08
FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations
Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1176-2023·2023-03-08
Sofsilk Coated Braided Silk Sutures recalled for sterile barrier breach
Covidien is recalling Sofsilk Coated Braided Silk Sutures due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss during ophthalmic procedures involving direct patient contact.
Product
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2023·2023-03-08
Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates
Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.
Product
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0377-2023·2023-03-08
FDA Recalls Accord Healthcare Buspirone 15 mg Tablets for Manufacturing Deviations
Accord Healthcare is recalling 10,992 bottles of Buspirone Hydrochloride 15 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0411-2023·2023-03-08
Simvastatin 40 mg tablets recalled for manufacturing practice deviations
Accord Healthcare is recalling 1,190,484 bottles of Simvastatin 40 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations identified during an FDA inspection.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1203-2023·2023-03-08
FDA Recalls Mobile X-Ray System for Erratic Movement Risk
SEDECAL's Phoenix mKDR Xpress mobile x-ray system is recalled due to three reported incidents of erratic movements. Seven units distributed in the US, Argentina, and Panama are affected.
Product
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0359-2023·2023-03-08
Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials distributed nationwide.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2023·2023-03-08
Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements
SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.
Product
Phoenix mKDR, digital mobile diagnostic x-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1184-2023·2023-03-08
Stryker Blood Loss Estimator Inserts Recalled for Inaccurate Measurement
Stryker is recalling Medivac Guardian 2L blood loss estimator inserts and labels for measurement inaccuracy. The device may output incorrect estimates, potentially delaying postpartum hemorrhage treatment.
Product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2023·2023-03-08
Dental Handpieces Recalled Due to Detachable Screw Component Risk
Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces because the screw connection between the turbine head and push button may loosen and fall off, creating a risk of swallowing or inhaling these parts.
Product
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0390-2023·2023-03-08
Peanut Butter Hot Chocolate and Cappuccino Recall for Undeclared Peanut Allergen
Corim Industries recalls Peanut Butter Hot Chocolate and Peanut Butter Cappuccino in multiple formats due to undeclared peanut allergen. Consumers with peanut allergies should not consume these products.
Product
Colonial Coffee, 12 ct single serve coffee pods (4.44 oz. carton)
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1172-2023·2023-03-08
Dermalon Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.
Product
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0412-2023·2023-03-08
Accord Healthcare Simvastatin 80 mg Tablets Recalled for Manufacturing Practice Violations
Accord Healthcare is recalling Simvastatin 80 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. Approximately 205,631 bottles are affected across the US, Puerto Rico, and Canada.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
1 state
HighFDA (Food)·F-0398-2023·2023-03-08
Safe + Fair Popcorn Recalled for Undeclared Peanut Residue
Safe + Fair Food Company's Key Lime Pie Drizzled Popcorn is being recalled due to the potential presence of undeclared peanut residue. Consumers with peanut allergies should not consume this product.
Product
The Safe + Fair Food Company Key Lime Pie Drizzled Popcorn Kettle Popped Net Wt. 7.5 oz (212g) Packaged in a plastic bags
Category
Food
Distribution
10 states
HighFDA (Drugs)·D-0417-2023·2023-03-08
Tadalafil Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare recalls Tadalafil 20 mg tablets due to CGMP deviations identified during FDA inspection. Approximately 613,553 bottles distributed in the US, Puerto Rico, and Canada are affected.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0357-2023·2023-03-08
FDA Recalls Norepinephrine Injection Due to Sterility Concerns
Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.
Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0397-2023·2023-03-08
Safe & Fair popcorn product recalled due to undeclared peanut residue
Snack Innovations Inc. is recalling Safe & Fair 7.5 oz drizzled popcorn Honey Crisp Apple Pie due to potential undeclared peanut residue. The product was distributed across multiple U.S. states.
Product
Safe & fair 7.5 oz drizzled popcorn Honey Crisp Apple Pie Packaged in a plastic bags
Category
Food
Distribution
10 states
HighFDA (Food)·F-0389-2023·2023-03-08
Peanut Butter Hot Chocolate and Cappuccino Recalled for Undeclared Peanut Allergen
Corim Industries is recalling Agglomerated Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products due to undeclared peanut allergen. People with peanut allergies who consume these products may experience allergic reactions.
Product
Jersey Charm, 24 ct single serve coffee pods (12.7 oz. carton)
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1174-2023·2023-03-08
Monosof nylon sutures recalled for sterile barrier breach
Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.
Product
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1178-2023·2023-03-08
Surgilon Braided Nylon sutures recalled due to sterile barrier defect
Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.
Product
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1199-2023·2023-03-08
Ultracell Wick with Collection Bag Recalled for Compromised Packaging Sterility
Beaver Visitec International recalls Ultracell Wick with 80cc Collection Bag due to packaging with potentially open seals that may compromise product sterility. The recall affects 4,640 units distributed across the United States and internationally.
Product
Ultracell Wick with 80cc Collection Bag, 20/box
Category
Medical Device
Distribution
27 states
HighFDA (Drugs)·D-0393-2023·2023-03-08
Accord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations
Accord Healthcare is recalling Glimepiride 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. The recall affects 469,944 bottles.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1206-2023·2023-03-08
X-ray System Overhead Crane May Continue Moving Unexpectedly
Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.
Product
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0396-2023·2023-03-08
Glycopyrrolate Injection, USP recalled for manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0355-2023·2023-03-08
Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles distributed nationwide.
Product
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·23V157000·2023-03-08
Eveland Scamp Travel Trailer Recall for Gas Leak Risk
Eveland's Inc. is recalling 2022 Scamp travel trailers because damaged burner control valves may cause a gas leak, increasing fire risk.
Product
EVELAND — EVELAND SCAMP
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0422-2023·2023-03-08
Pravastatin Sodium tablets recalled for manufacturing practice violations
Accord Healthcare is recalling Pravastatin Sodium 20 mg tablets following an FDA inspection that identified manufacturing practice deviations. Approximately 32,688 bottles were distributed in the United States, Puerto Rico, and Canada.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0358-2023·2023-03-08
Injectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure
FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.
Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0414-2023·2023-03-08
Tadalafil tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling Tadalafil 2.5 mg tablets following discovery of manufacturing deviations during an FDA inspection. Approximately 36,773 bottles were distributed in the United States, Puerto Rico, and Canada.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0421-2023·2023-03-08
Pravastatin Sodium Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Pravastatin Sodium 10 mg tablets for CGMP deviations found during FDA inspection. About 9,600 bottles were distributed across the United States, Puerto Rico, and Canada. No illnesses reported.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0368-2023·2023-03-08
Aripiprazole 15 mg Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Aripiprazole 15 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during an FDA inspection.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0382-2023·2023-03-08
Daptomycin Injectable Recalled Due to Manufacturing Deviations
Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries have been reported.
Product
DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0428-2023·2023-03-08
Ropinirole Tablets Recalled by Accord Healthcare Following FDA Inspection
Accord Healthcare is recalling 25,344 bottles of Ropinirole 2 mg tablets due to manufacturing deviations discovered during an FDA inspection. The recall affects medications distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0363-2023·2023-03-08
Fentanyl Injection Syringes Recalled for Subpotent Active Ingredient
SCA Pharmaceuticals is recalling 2,125 fentanyl injection syringes nationwide due to subpotency—the product contains less active ingredient than labeled. The firm voluntarily initiated this Class III recall in February 2023.
Product
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0383-2023·2023-03-08
Prescription Drug Dofetilide Recalled Due to Manufacturing Compliance Deviations
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing deviations found during an FDA inspection. The recall involves 37,790 bottles distributed across the United States, Puerto Rico, and Canada.
Product
DOFETILIDE — DOFETILIDE (DOFETILIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0404-2023·2023-03-08
Rosuvastatin Tablets 5mg Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Rosuvastatin tablets 5mg due to manufacturing practice deviations found during an FDA inspection. The recall involves 63,247 bottles distributed across the U.S., Puerto Rico, and Canada.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0431-2023·2023-03-08
Ropinirole Tablets Recalled Due to Manufacturing Quality Violations
Accord Healthcare is recalling Ropinirole 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 5,112 bottles distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-0395-2023·2023-03-08
Drizzilicious Mini Rice Cake Bites Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites for possible undeclared peanut residue. Consumers with peanut allergies should not consume the product.
Product
Drizzilicious Mini Rice Cake bites Net Wt. 4oz and/or .74oz Bags Salted Caramel UPC:857900005167 and 857900005181 Packaged in a plastic bags Product also packed in the Drizzilicious mini rice cakes 32-ct Variety box
Category
Food
Distribution
10 states
ModerateFDA (Drugs)·D-0376-2023·2023-03-08
Accord Healthcare Recalls Buspirone Hydrochloride Due to Manufacturing Deviations
Accord Healthcare is recalling 24,408 bottles of Buspirone Hydrochloride tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0354-2023·2023-03-08
Gabapentin 600 mg Tablets Recalled Due to Dosage Strength Mix-Up
Sciegen Pharmaceuticals is recalling 4,392 bottles of Gabapentin 600 mg tablets after a pharmacist discovered some 800 mg tablets mixed into bottles.
Product
GABAPENTIN — GABAPENTIN (GABAPENTIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0413-2023·2023-03-08
Accord Recalls Succinylcholine Chloride Injection Due to Manufacturing Deviations
Accord Healthcare is recalling Succinylcholine Chloride Injection due to manufacturing practice deviations discovered during FDA inspection. The recall affects 48,089 cartons distributed to the U.S., Puerto Rico, and Canada.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC…
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0401-2023·2023-03-08
Accord Healthcare recalls phenylephrine injection vials due to manufacturing deviations
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing deviations found during FDA inspection. No illnesses or injuries have been reported.
Product
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton…
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0353-2023·2023-03-08
Prescription Levothyroxine Sodium Tablets Recalled Due to Sub-Potency
Alvogen is recalling 21,276 bottles of Levothyroxine Sodium Tablets (Lot HE02221, expiration 05/2023) distributed nationwide and in Puerto Rico due to sub-potency.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0370-2023·2023-03-08
Prescription drug aripiprazole tablets recalled for manufacturing practice deviations
Accord Healthcare is recalling aripiprazole tablets (30 mg) due to manufacturing practice deviations found during an FDA inspection. The recall covers 88,728 bottles distributed to the United States, Puerto Rico, and Canada.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0367-2023·2023-03-08
Aripiprazole Tablets Recalled Following FDA Inspection for Manufacturing Deviations
Accord Healthcare recalls 539,004 bottles of Aripiprazole 10 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing process deviations found during an FDA inspection.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0385-2023·2023-03-08
FDA Recalls Dofetilide Antiarrhythmic Drug for Manufacturing Deviations
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., Puerto Rico, and Canada.
Product
DOFETILIDE — DOFETILIDE (DOFETILIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0410-2023·2023-03-08
Simvastatin Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Simvastatin 20 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. The recall affects 1,394,208 bottles distributed in the United States, Puerto Rico, and Canada.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0378-2023·2023-03-08
Accord Healthcare Recalls Buspirone Hydrochloride Tablets Due to Manufacturing Violations
Accord Healthcare is recalling Buspirone Hydrochloride tablets due to manufacturing process deviations found during an FDA inspection. The recall affects approximately 3,784 bottles distributed in the United States, Puerto Rico, and Canada.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0350-2023·2023-03-08
DuPont Avicel PH-102 Microcrystalline Cellulose Recalled for Conductivity Specification Failure
DuPont Nutrition USA is recalling Avicel PH-102 NF microcrystalline cellulose excipient due to failed conductivity specifications indicating potential impurities. The product was distributed nationwide and internationally.
Product
Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0394-2023·2023-03-08
Glimepiride 2 mg tablets recalled for manufacturing practice deviations
Accord Healthcare recalls Glimepiride 2 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. Approximately 992,622 bottles across multiple batches are affected.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0390-2023·2023-03-08
Finasteride tablets recalled for manufacturing practice deviations
Accord Healthcare recalls 325,356 bottles of Finasteride 1 mg tablets due to manufacturing practice deviations identified during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
Product
FINASTERIDE — FINASTERIDE (FINASTERIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0380-2023·2023-03-08
Clopidogrel Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Clopidogrel Tablets USP 75 mg due to manufacturing practice deviations found during an FDA inspection. Approximately 1.4 million bottles distributed across the US, Puerto Rico, and Canada are affected.
Product
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc.…
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0389-2023·2023-03-08
Accord Healthcare Doxazosin Tablets Recalled for Manufacturing Deviations
Accord Healthcare recalls 31,116 bottles of Doxazosin Tablets USP 8 mg due to manufacturing practice deviations identified during FDA inspection. Distribution covered the US, Puerto Rico, and Canada.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0400-2023·2023-03-08
Accord Healthcare Recalls Montelukast Sodium Tablets Due to Manufacturing Deviations
Accord Healthcare recalls approximately 665,469 bottles of Montelukast Sodium 10 mg tablets due to manufacturing process deviations discovered during FDA inspection.
Product
MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0392-2023·2023-03-08
Finasteride 5 mg Tablets Recalled Due to Manufacturing Process Deviations
Accord Healthcare is recalling Finasteride 5 mg tablets due to manufacturing process deviations discovered during FDA inspection. Over 2.7 million bottles distributed in the US, Puerto Rico, and Canada are affected.
Product
FINASTERIDE — FINASTERIDE (FINASTERIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0426-2023·2023-03-08
Ropinirole Tablets Recalled for Manufacturing Practice Deviations
Accord Healthcare recalls 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the U.S., Canada, and Puerto Rico due to manufacturing practice deviations identified during an FDA inspection.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0375-2023·2023-03-08
Buspirone Hydrochloride tablets recalled for manufacturing practice deviations
Accord Healthcare is recalling Buspirone Hydrochloride 7.5 mg tablets (23,784 bottles) distributed in the US, Puerto Rico, and Canada due to manufacturing practice deviations identified during FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0381-2023·2023-03-08
Daptomycin injection recalled due to manufacturing compliance deviations
Accord Healthcare recalls Daptomycin for Injection in the US, Puerto Rico, and Canada affecting 65,233 vials due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection.
Product
DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0387-2023·2023-03-08
Prescription Doxazosin Tablets Recalled for Manufacturing Deviations
Accord Healthcare is recalling Doxazosin 2 mg tablets distributed across the United States, Puerto Rico, and Canada due to manufacturing practice deviations identified during an FDA inspection.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0418-2023·2023-03-08
Vigabatrin Oral Solution Recalled for Manufacturing Quality Deviations
Accord Healthcare is recalling 821 cartons of Vigabatrin for Oral Solution due to manufacturing quality deviations found during an FDA inspection. The product was distributed in the United States, Puerto Rico, and Canada.
Product
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC…
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0349-2023·2023-03-08
Microcrystalline Cellulose Ingredient Recalled Over Failed Impurity Specifications
DuPont Nutrition USA, Inc. is recalling certain batches of Avicel PH-101 microcrystalline cellulose because it failed quality testing for impurities and degradation. The ingredient showed out-of-specification conductivity levels.
Product
Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0386-2023·2023-03-08
Prescription Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found during an FDA inspection.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0409-2023·2023-03-08
Simvastatin tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling Simvastatin 10 mg tablets distributed in the U.S., Puerto Rico, and Canada due to manufacturing process deviations discovered during FDA inspection. Patients should contact their pharmacy or healthcare provider.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0419-2023·2023-03-08
Pirfenidone tablets recalled due to manufacturing process deviations
Accord Healthcare recalls Pirfenidone tablets due to manufacturing practice deviations found during FDA inspection. The recall affects 2,614 cartons distributed in the US, Puerto Rico, and Canada.
Product
PIRFENIDONE — PIRFENIDONE (PIRFENIDONE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0398-2023·2023-03-08
Glycopyrrolate injection recalled due to manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
1 state

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