HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded
Summary
The FDA issued a Class I for HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, N by Revive Rx LLC dba Revive Rx Pharmacy. Reason: Non-sterility; bacterial contamination identified as Paenibacillus lautus..
Details
Source
Drug Recall
External ID
D-0648-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
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/Code Info: Lot: 631359 BUD: 05/01/2022
Quantity Affected: 115 vials
Reason for Recall
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-11
Company
Houston, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Revive Rx LLC dba Revive Rx Pharmacy has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Revive Rx LLC dba Revive Rx Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Revive Rx LLC dba Revive Rx Pharmacy have FDA actions?
Revive Rx LLC dba Revive Rx Pharmacy has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0648-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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