Recalls / Class II
Class IID-0343-2019
Product
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
- Affected lot / code info
- Lot: 10292018:21 Exp. 3/31/2019
Why it was recalled
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, Houston, Texas 77054-4010
Distribution
- Quantity
- 85 vials
- Distribution pattern
- WA
Timeline
- Recall initiated
- 2018-11-19
- FDA classified
- 2018-12-20
- Posted by FDA
- 2018-12-26
- Terminated
- 2020-10-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0343-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.