Drug Enforcement D-0385-2025

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

Status

Ongoing

Classification

Class III

Report Date

April 30, 2025

Termination Date

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Product Information

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.
Product quantity
1,375 cassettes
Reason for recall
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
OurPharma LLC
Address
2512 S City Lake Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0385-2025
Event ID
96706
Recall initiation date
April 15, 2025
Center classification date
April 21, 2025
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
More code info
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