Recalls / Class I
Class ID-0633-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot Number: 21104221A, Expiration date: 05-22-2022
Why it was 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
Recalling firm
- Firm
- STAQ Pharma, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 14135 E 42nd Ave Ste 50, N/A, Denver, Colorado 80239-5214
Distribution
- Quantity
- 905 Syringes
- Distribution pattern
- CO, OH, and TX.
Timeline
- Recall initiated
- 2022-02-03
- FDA classified
- 2022-02-25
- Posted by FDA
- 2022-02-23
- Terminated
- 2022-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0633-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.