Why it was recalled
Sub-potency
Product description
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
Lot numbers, UPCs & expiration codes
Lot: 01/14/19 0215 22110P Exp. 04/29/2019
Where it was sold
Nationwide in the US
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-1251-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 26, 2019
- FDA report date
- May 8, 2019
- Quantity
- 560 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1251-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82718
- Address
- 9265 Kirby Dr
- Code information
- Lot: 01/14/19 0215 22110P Exp. 04/29/2019
- Postal code
- 77054-2520
- Report date
- May 8, 2019
- Product type
- Drugs
- Recall number
- D-1251-2019
- Classification
- Class II
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 560 bags
- Termination date
- Oct 30, 2019
- Reason for recall
- Sub-potency
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Apr 26, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 29, 2019