Recalls / Class II
Class IID-0156-2019
Product
HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10
- Affected lot / code info
- Lot: 04252018:33 Discard by: 10/21/2018; 05082018:39 Discard by: 11/4/2018; 06262018:00 Discard by: 12/23/2018; 07192018:13 Discard by: 1/15/2019; 08012018:46 Discard by: 1/28/2019; 08212018:69 Discard by: 11/30/2018
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
- 2219 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-0156-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.