CLASS I Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
HYDROmorphone HCl PF 10 mg/ (0.2mg/mL) in NaCl recalled by STAQ Pharma
Staq Pharma is recalling HYDROmorphone HCl PF 10 mg/ (0.2mg/mL) in NaCl in Single Dose Syringe, distributed in Colorado, Ohio, Texas. The recall was initiated on 3 Feb 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0633-2022
- FDA event ID
- 89550
- Recalling firm
- Staq Pharma, Denver, CO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Feb 2022
- FDA classified
- 25 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 3 Feb 2022 | Recall initiated by company | |
| 23 Feb 2022 | Published in enforcement report | +20 days |
| 25 Feb 2022 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
CO, OH, and TX.
Questions about this recall
Why was it recalled?
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Which lots are affected?
Lot Number: 21104221A, Expiration date: 05-22-2022
Where was it sold?
CO, OH, and TX.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 89550| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Morphine Sulfate PF 25 mg/ (1 mg/mL) in NaCl in Single Dose Syringe recalled | Staq Pharma | Labeling Errors | CO, OH, TX |
More recalls from Staq Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS III | Hydromorphone HCL PF, 10mg/ (0.2mg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS III | Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled | Staq Pharma | Other | Nationwide |
| Drug | CLASS II | ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg recalled | Staq Pharma | Packaging Defects | Nationwide |
| Drug | CLASS I | Morphine Sulfate PF 25 mg/ (1 mg/mL) in NaCl in Single Dose Syringe recalled | Staq Pharma | Labeling Errors | CO, OH, TX |
Other Hydromorphone Pf recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydromorphone HCL PF, 10mg/ (0.2mg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS, Qty recalled | Lincare | Sterility | AR |
| Drug | CLASS II | HYDROmorphone HCl PF, Hydromorphone HCL 1000mg /NS, Qty recalled | Lincare | Sterility | AR |
| Drug | CLASS II | Hydromorphone HCl (PF) 1 mg/mL injectable recalled | Martin Avenue Pharmacy | Sterility | Nationwide |