Drug recall: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint)
Presence of foreign substance — ANI Pharmaceuticals, Inc. · Class III · Ongoing · 6564 bottles
Recalls and safety alerts from the FDA, newest first.
Presence of foreign substance — ANI Pharmaceuticals, Inc. · Class III · Ongoing · 6564 bottles
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing · 3,456 30-count bottles
CGMP Deviations — Amgen, Inc. · Class II · Ongoing · N/A
CGMP Deviations — Amgen, Inc. · Class II · Ongoing · 9565 bottles
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. — CareFusion 213, LLC · Class I · Ongoing · 178,000 applicators
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infec… — Dexcom, Inc. · Class II · Ongoing · N/A
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 112 units
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 435 units
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition. — Ventec Life Systems, Inc. · Class II · Ongoing · 1
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Potential for thrombus formation during prolonged use of the introducer. — Abiomed, Inc. · Class I · Ongoing · 168 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 0
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. — Medline Industries, LP · Class II · Ongoing · 113,843 kits
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. — Philips North America Llc · Class II · Ongoing · 285 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · N/A
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Medtronic Perfusion Systems · Class II · Ongoing · 288 units
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. — Zimmer, Inc. · Class II · Ongoing · 13 units
Potential for thrombus formation during prolonged use of the introducer. — Abiomed, Inc. · Class I · Ongoing · 17 units
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). — SURGIFY MEDICAL OY · Class II · Ongoing · 8 units
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique. — Stryker Neurovascular · Class II · Ongoing · 44,937
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient… — Intuitive Surgical, Inc. · Class II · Ongoing · 454