HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake
Summary
The FDA issued a Class III for HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx by OurPharma LLC. Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification...
Details
Source
Drug Recall
External ID
D-0385-2025
Action Date
2025-04-30
Status
Terminated
Category
drug
Product Description
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
Lot/Code Info: 104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
Quantity Affected: 1,375 cassettes
Reason for Recall
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-15
Company
Fayetteville, AR
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 56 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
OurPharma LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (OurPharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OurPharma LLC have FDA actions?
OurPharma LLC 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-0385-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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