FDA Recall D-0575-2018
Advanced Pharma Inc. · Houston, TX
Class I — life-threatening Terminated 608 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10
Reason for recall
Subpotent
Recall record
- Recall number
D-0575-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Texas
- Recall initiated
- 2018-01-05
- Classified by FDA Center
- 2018-03-01
- FDA published
- 2018-01-31
- Terminated
- 2019-09-05
- Recalling firm
- Advanced Pharma Inc.
- Firm location
- Houston, TX