Skip to content
Recall Observatory FDA recall evidence

Drug product

N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

D-0011-2015

July 18, 2014

Class I

Product summary

Firm
Unique Pharmaceutical, Ltd
Event
Event 68841
Status
Terminated
Classification
Class I
Quantity
3,529 Vials
Official record key
drug-enforcement:D-0011-2015

Official wording

Reason: Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

Code information: Lot #: 86513, Exp 07/23/2014

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.