Recalls / Class I
Class ID-0575-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot: 12/22/17 1422 108-90710P UD: 3/22/2018
Why it was recalled
Subpotent
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, N/A, Houston, Texas 77054-2520
Distribution
- Quantity
- 25 bags
- Distribution pattern
- Texas
Timeline
- Recall initiated
- 2018-01-05
- FDA classified
- 2018-03-01
- Posted by FDA
- 2018-01-31
- Terminated
- 2019-09-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0575-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.