Why it was recalled
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 631359 BUD: 05/01/2022
Where it was sold
Nationwide in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0648-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 11, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 115 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
Original FDA data
Every field from FDA enforcement report D-0648-2022, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 89591
- Address
- 3831 Golf Dr Ste A
- Code information
- Lot: 631359 BUD: 05/01/2022
- Postal code
- 77018-5218
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0648-2022
- Classification
- Class I
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
- Product quantity
- 115 vials
- Termination date
- Aug 23, 2024
- Reason for recall
- Non-sterility; bacterial contamination identified as Paenibacillus lautus.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Feb 11, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 8, 2022