FDA Recall D-0633-2022

STAQ Pharma, Inc. · Denver, CO

Class I — life-threatening Terminated 225 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.

Lot / code: Lot Number: 21104221A, Expiration date: 05-22-2022

Quantity: 905 Syringes

Reason for recall

Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A

Recall record

Recall number: D-0633-2022
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: CO, OH, and TX.
Recall initiated: 2022-02-03
Classified by FDA Center: 2022-02-25
FDA published: 2022-02-23
Terminated: 2022-09-16
Recalling firm: STAQ Pharma, Inc.
Firm location: Denver, CO

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