Why it was recalled
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Product description
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
Lot numbers, UPCs & expiration codes
Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19
Where it was sold
Nationwide in the USA.
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-0498-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 6, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 672 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0498-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 82089
- Address
- 9265 Kirby Dr
- Code information
- Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19
- Postal code
- 77054-2520
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0498-2019
- Classification
- Class III
- Recalling firm
- Advanced Pharma Inc.
- Product quantity
- 672 bags
- Termination date
- Oct 30, 2019
- Reason for recall
- Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2019