Recalls / Class II
Class IID-0936-2018
Product
MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10
- Affected lot / code info
- Lot # 5/1/18 0501 548-90510P, BUD 7/30/2018.
Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
Recalling firm
- Firm
- Avella of Deer Valley, Inc. Store 38
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24416 N 19th Ave, Phoenix, Arizona 85085-1887
Distribution
- Quantity
- 100 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-06-12
- FDA classified
- 2018-07-19
- Posted by FDA
- 2018-07-25
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0936-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.