The Recall Desk
CriticalFDA (Drugs)·D-0648-2022·Announced 2022-02-23

HCG 6,000iu Injection Recalled for Bacterial Contamination

Revive Rx is recalling HCG 6,000iu injectable medication due to bacterial contamination (Paenibacillus lautus) identified in the product. The affected lot was distributed nationwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall is classified as FDA Class I by the issuing agency, which mandates a severity score of at least 4. Injectable medications with bacterial contamination present a critical patient safety risk, especially given the route of administration (subcutaneous or intramuscular) and the inability to achieve sterility—a fundamental requirement for injectable products.

Plain-English summary

Revive Rx LLC dba Revive Rx Pharmacy is recalling HCG 6,000iu (lyo) Human Chorionic Gonadotropin Injectable due to non-sterility and bacterial contamination. The contaminating organism has been identified as Paenibacillus lautus.

The affected product is HCG 6,000iu vials for subcutaneous or intramuscular injection only (not for intravenous use), manufactured by Revive Rx and distributed nationwide in the United States. The recalled lot is 631359 with a Beyond Use Date of 05/01/2022. A total of 115 vials are subject to this recall.

Patients who have received this medication should consult their healthcare provider immediately. Healthcare providers and patients should not use the recalled lot and should contact Revive Rx for further instructions regarding return or disposal.

The recalled product

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.
Manufacturer
Revive Rx LLC dba Revive Rx Pharmacy
Category
Drug — Injectable / Compounded
Hazard
  • bacterial-contamination
  • non-sterility
  • paenibacillus-lautus

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 631359 BUD: 05/01/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category