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D-0648-2022 Class I Terminated

Recalled by Revive Rx LLC Dba Revive Rx Pharmacy — Houston, TX

FDA drug recall D-0648-2022 was initiated by Revive Rx LLC Dba Revive Rx Pharmacy on Feb 11, 2022 and is designated Class I. Reason for recall: Non-sterility; bacterial contamination identified as Paenibacillus lautus. The recall status is terminated (terminated Aug 23, 2024). Affected quantity: 115 vials.

Recall Details

Product Type: Drugs
Report Date: Feb 23, 2022
Initiation Date: Feb 11, 2022
Termination Date: Aug 23, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 115 vials

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.

Reason for Recall

Non-sterility; bacterial contamination identified as Paenibacillus lautus.

Distribution Pattern

Nationwide in the US.

Code Information

Lot: 631359 BUD: 05/01/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0648-2022
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.