Recalls / Class II
Class IID-0178-2019
Product
Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50
- Affected lot / code info
- Lot: 03262018:11 Discard by: 4/25/2018; 04102018:38 Discard by: 5/10/2018; 05312018:63 Discard by: 6/30/2018; 05032018:97 Discard by: 6/2/2018; 06082018:24 Discard by: 7/8/2018; 05212018:80 Discard by: 6/20/2018; 07102018:60 Discard by: 8/9/2018; 06202018:44 Discard by: 7/19/2018; 07232018:08 Discard by: 8/22/2018; 07022018:62 Discard by: 8/1/2018; 08292018:95 Discard by: 9/28/2018; 08202018:61 Discard by: 9/19/2018
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, N/A, Houston, Texas 77054-4010
Distribution
- Quantity
- 517 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-10
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-11-07
- Terminated
- 2021-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0178-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.