PlainRecalls
FDA Drug Low Class III Ongoing

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.

Reported: April 30, 2025 Initiated: April 15, 2025 #D-0385-2025

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.

Reason for Recall

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

Details

Recalling Firm
OurPharma LLC
Units Affected
1,375 cassettes
Distribution
Nationwide in the USA
Location
Fayetteville, AR

Frequently Asked Questions

What product was recalled?
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.. Recalled by OurPharma LLC. Units affected: 1,375 cassettes.
Why was this product recalled?
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Which agency issued this recall?
This recall was issued by the FDA Drug on April 30, 2025. Severity: Low. Recall number: D-0385-2025.