Latest recalls — page 254
Older notices, newest first.
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Class II · 12 months ago
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class I · 12 months ago
IMPRIS Imaging Inc IMRIS Operating Suite, InVision 3T Operating Suite recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
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Class II · 12 months ago
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Daye 18 Coated Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Refill 3 Month Regular Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye 9 Coated Super Tampons and 9 Nude Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Refill 18 Coated Regular and 18 Nude Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Daye Refill 3 Month All in One Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class I · 12 months ago
IMPRIS Imaging Inc IMRIS Operating Suite, Neuro III-SV iMRI System recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
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Class II · 12 months ago
Philips Medical Systems Model: Incisive CT for Brazil SKD recall: Issue 1: The potential for unintentional continued gantry/couch movement
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2…
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Class II · 12 months ago
Alcon Precision1 One-Day Contact Lenses, -2.25D recall: Potential for a weak seal in some units resulting in compromise in sterility
Potential for a weak seal in some units resulting in compromise in sterility.
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Class II · 12 months ago
Heritage Pharmaceuticals Inc Desipramine Hydrochloride Tablets, USP, 75 mg recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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Class II · 12 months ago
Sun Pharmaceutical Industries Inc Lisdexamfetamine Dimesylate Capsules, 30 mg recall: Failed Dissolution Specifications: An out of specification results observed
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
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Class III · 12 months ago
Endo USA, Inc. Everolimus tablets 5mg, 28 tablets recall: Failed Impurities/Degradation Specifications: Out of specification
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone 87.5 MG, 1 Pellet FOR Subcutaneous Insertion recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
Sun Pharmaceutical Industries Inc Lisdexamfetamine Dimesylate Capsules, 40 mg recall: Failed Dissolution Specifications: An out of specification results observed
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
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Class III · 12 months ago
Endo USA, Inc. Everolimus tablets 10 mg, 28 tablets recall: Failed Impurities/Degradation Specifications: Out of specification
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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Class II · 12 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP, 60 mg recall: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
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Class II · 12 months ago
Sun Pharmaceutical Industries Inc Lisdexamfetamine Dimesylate Capsules, 10 mg recall: Failed Dissolution Specifications: An out of specification results observed
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
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Class II · 12 months ago
Teva Pharmaceuticals USA, Inc Prazosin Hydrochloride, Capsules, USP, 5 mg recall: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone Regular Release 200 MG recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
Sun Pharmaceutical Industries Inc Lisdexamfetamine Dimesylate Capsules, 20 mg recall: Failed Dissolution Specifications: An out of specification results observed
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
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Class II · 12 months ago
QuVa Pharma, Inc. R.e.c.k. in Sodium Chloride Solution, Total Volume: 50 mL syringe recall: Presence of Particulate Matter
Presence of Particulate Matter