FDA Recall D-0347-2019
Advanced Pharma Inc. · Houston, TX
Class I — life-threatening Terminated 154 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Reason for recall
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Recall record
- Recall number
D-0347-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Heath care facilities in NM, TX, and OH
- Recall initiated
- 2018-11-29
- Classified by FDA Center
- 2019-01-07
- FDA published
- 2019-01-02
- Terminated
- 2019-05-02
- Recalling firm
- Advanced Pharma Inc.
- Firm location
- Houston, TX