All sterile products within expiry

FDA recall notice · announced October 15, 2014 · Unique Pharmaceutical

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

All sterile products within expiry

Reason for recall

Lack 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.

Notes

Distribution: Nationwide
Lot/code information: All Lots
Quantity: 325,225 units (syringes, vials, bags)
Status: Terminated
Products in this recall event:
- N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 (D-0011-2015)
- All sterile products within expiry (D-0012-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.