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
Product description
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 numbers, UPCs & expiration codes
Lot Number: 21104221A, Expiration date: 05-22-2022
Where it was sold
CO, OH, and TX.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0633-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 3, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 905 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- STAQ Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0633-2022, exactly as published.
Show all FDA fields
- City
- Denver
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 89550
- Address
- 14135 E 42nd Ave Ste 50
- Code information
- Lot Number: 21104221A, Expiration date: 05-22-2022
- Postal code
- 80239-5214
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0633-2022
- Classification
- Class I
- Recalling firm
- STAQ Pharma, Inc.
- Product quantity
- 905 Syringes
- Termination date
- Sep 16, 2022
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- CO, OH, and TX.
- Recall initiation date
- Feb 3, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 25, 2022