Class II · Moderate risk
Bpc-157
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
Aod-9604
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Pt-141
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Fgl, 10 Mg/Ml
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Cjc-1295
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class I · High risk
Class I · High risk
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Fentanyl-Bupivacaine HCL Pf Injectable 3000mcg-12mg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Lioresal Pf Injectable 7.5mg-1625mcg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Non-Sterility
Class II · Moderate risk
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Lack of Assurance of Sterility
Class II · Moderate risk
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 50 mg Infusion
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Lack of Assurance of Sterility
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