Recalls / Class II
Class IID-0169-2019
Product
Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC 69699-1203-50
- Affected lot / code info
- Lot: 03152018:12 Discard by: 6/13/2018; 04182018:08 Discard by: 7/17/2018; 04302018:94 Discard by: 7/29/2018; 03292018:44 Discard by: 6/26/2018; 05212018:95 Discard by: 8/19/2018; 06142018:46 Discard by: 9/12/2018; 05312018:37 Discard by: 8/29/2018; 06282018:80 Discard by: 9/26/2018; 07312018:12 Discard by: 10/29/2018; 07102018:53 Discard by: 10/8/2018; 08222018:18 Discard by: 11/20/2018
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
- 264 vials
- 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-0169-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.