RecallRadar

FDA Drug recall D-0011-2015

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

On 2014-10-15 the FDA classified a Class I recall of N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 by Unique Pharmaceutical, citing non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0011-2015
ClassificationClass I
Statusterminated
Initiated2014-07-18
Published2014-10-15
Last updated2026-09-13 11:51 UTC
CompanyUnique Pharmaceutical
DistributionUS

Product

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

Reason

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

Identifiers

code_infoLot #: 86513, Exp 07/23/2014

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0011-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.