Recalls / Class II
Class IID-1019-2019
Product
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Affected lot / code info
- Lots: 12/03/18 9479 40105P Exp. 4/2/2019; 12/3/18 6583 40105P Exp. 4/2/2019; 12/3/18 8918 40105P Exp. 4/2/2019; 12/03/18 4727 40105P Exp. 4/2/2019
Why it was recalled
Lack of Assurance of Sterility
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
- 1125 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-03-13
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Terminated
- 2020-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1019-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.