Drug 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.
D-0633-2022
Product summary
- Event
- Event 89550
- Status
- Terminated
- Classification
- Class I
- Quantity
- 905 Syringes
- Official record key
drug-enforcement:D-0633-2022
Official wording
Reason: Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Code information: Lot Number: 21104221A, Expiration date: 05-22-2022
Distribution pattern: CO, OH, and TX.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix up