FDA Recall D-0648-2022
Revive Rx LLC dba Revive Rx Pharmacy · Houston, TX
Class I — life-threatening Terminated 924 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
Reason for recall
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Recall record
- Recall number
D-0648-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US.
- Recall initiated
- 2022-02-11
- Classified by FDA Center
- 2022-03-08
- FDA published
- 2022-02-23
- Terminated
- 2024-08-23
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
- Firm location
- Houston, TX