Class II · Moderate risk
Papa/Phen/Prost
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
Papa/Phen/Prost
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
Succinylcholine Chloride
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Class II · Moderate risk
Travoprost Ophthalmic Solution USP
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Class II · Moderate risk
USCG Boat Response Kit - Product Code 80-0353
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Aid Backpack Kit - Product Code 85-0917
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Mini Resupply Trauma Kit - Product Code 85-0835
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Amphibious Trauma Kit - Product Code 85-0639
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
K-9 Trauma Field Kit - Product Code 80-0211
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Advance Trauma Kit - Product Code 85-0742
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit - Product Code 85-1274
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit ORG - Product Code 80-0213
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit Hardcase - Product Code 85-0889
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class I · High risk
Lidocaine HCL/ Sodium Bicarb
Non-Sterility: failed sterility test result.
Class II · Moderate risk
Testosterone Cypionate in Sesame Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate in Grapeseed Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 in Sesame Oil Injectable 50
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 in Sesame Oil Injectable 100
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Test 200
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Injectable 30 mg/3 mg/60 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Injectable 30 mg/3 mg/100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Injectable 30 mg/1 mg/25 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL
Lack of Assurance of Sterility