Unique Pharmaceutical recalls
FDA enforcement reports naming Unique Pharmaceutical, Ltd as the recalling firm.
- Recall reports
- 3
- Class I (serious)
- 1
- Most recent report
- Oct 15, 2014
- Oct 15, 2014N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133Drug · Unique Pharmaceutical, LtdNon-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.Class I
- Oct 15, 2014All sterile products within expiryDrug · Unique Pharmaceutical, LtdLack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.Class II
- Sep 24, 2014NORepinephrine 4 mg in 250 mL Sodium Chloride0Drug · Unique Pharmaceutical, LtdLack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.Class II