FDA Recall D-0011-2015
Unique Pharmaceutical, Ltd · Temple, TX
Class I — life-threatening Terminated 586 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Reason for recall
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Recall record
- Recall number
D-0011-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2014-07-18
- Classified by FDA Center
- 2014-10-09
- FDA published
- 2014-10-15
- Terminated
- 2016-02-24
- Recalling firm
- Unique Pharmaceutical, Ltd
- Firm location
- Temple, TX