Recalls / Class II
Class IID-1024-2019
Product
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Affected lot / code info
- Lots: 11/02/18 9350 82967S Exp. 4/1/2019; 10/23/18 1471 82967S Exp. 3/22/2019; 10/24/18 4412 82967S Exp. 3/23/2019; 10/24/18 0733 82967S Exp. 3/22/2019
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
- 5700 syringes
- 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-1024-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.