Recalls / Class II
Class IID-0368-2016
Product
L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
- Affected lot / code info
- All lots
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Downing Labs, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 4001 McEwen Rd Suite 110, N/A, Dallas, Texas 75244-5020
Distribution
- Quantity
- 32 vials
- Distribution pattern
- Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Timeline
- Recall initiated
- 2015-10-16
- FDA classified
- 2015-11-18
- Posted by FDA
- 2015-11-25
- Terminated
- 2016-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0368-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.