Class II · Moderate risk
Biest Cp 80/20
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Biest Cp 80/20
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Biest Cp 76/24: Dhea
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Biest 80/20 : Progest : Dhea : Testost
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Biest 66/34: Testosterone : Progesterone in Olive Oil
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Fomepizole Injection
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit)
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class II · Moderate risk
5% DEXTROSE Injection
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Class II · Moderate risk
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters
Failed dissolution specifications
Class II · Moderate risk
Haloperidol Oral Solution
Defective Container: Confirmed customer complaints of leaking bottles.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class II · Moderate risk
RIFAMPIN for Injection
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Colistimethate for Injection USP
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Droperidol injection
Presence of particulate.
Class II · Moderate risk
Promethazine Dm Syrup
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class II · Moderate risk
Ketorolac Trom 30 Mg/Ml Inj
Crystallization
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk
Amlodipine Besylate Tablets USP
Failed tablet specifications: One lot was found to contain oversized tablets.
Class II · Moderate risk
Phen 15 mg - Topri 92 mg SR Cap
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Hydrocortisone 1.6 mg/0.5 mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Nystatin 50
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.