Recalls / Class II
Class IID-0160-2019
Product
HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12
- Affected lot / code info
- Lot: 04092018:58 Discard by: 10/6/2018; 06072018:03 Discard by: 12/4/2018; 05292018:86 Discard by: 11/25/2018; 07192018:64 Discard by: 1/15/2019; 08302018:30 Discard by: 2/26/2019
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
- 881 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-0160-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.