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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 115
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.
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