Medications & Supplements/Prescription Drugs

Advanced Pharma Inc.: Oxytocin Injectable Solution Recalled for Superpotency

Agency Publication Date: February 15, 2019

Summary

Advanced Pharma Inc. is recalling 2,144 bags and bottles of Oxytocin (added to 0.9% Sodium Chloride) Injectable Solution because the product may contain significantly higher concentrations of the drug than stated on the label. This recall involves 10 Unit, 20 Unit, and 30 Unit sterile single-use bags distributed nationwide across the United States. Consumers or healthcare facilities using these products should be aware that superpotent medication can cause severe medical complications during labor and delivery. If you are in possession of this product, you should contact your healthcare provider or pharmacist immediately for guidance.

Risk

Superpotent oxytocin can cause excessively strong uterine contractions during labor. This poses a significant risk of uterine rupture, fetal distress, or other serious maternal and fetal complications.

What You Should Do

Identify if you have the affected product by checking the labels for Oxytocin Injectable Solution from Avella of Houston with NDC numbers 42852-730-99, 42852-703-99, or 42852-706-50.
Check for Oxytocin 10 Units with Lot 12/20/18 1056 73099P (BUD: 02/03/2019).
Check for Oxytocin 20 Units with Lots 12/14/18 1482 70399P or 12/14/18 1610 70399P (BUD: 02/27/19).
Check for Oxytocin 30 Units with Lots 11/27/18 3177 70650P, 11/27/18 6618 70650P (BUD: 02/10/2019), 11/28/18 7716 70650P (BUD: 02/12/19), or 12/31/18 5698 70650P (BUD: 03/16/19).
Contact your healthcare provider or pharmacist immediately for guidance if you have been administered this product or have it in your inventory.
Return any unused product to the pharmacy or place of purchase for a refund.
Contact the manufacturer, Advanced Pharma Inc. (Avella of Houston), at 9265 Kirby Dr, Houston, Texas, 77054-2520 for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution (1001 mL)

Model:

NDC 42852-730-99

D-0497-2019

Lot Numbers:

12/20/18 1056 73099P

Date Ranges: BUD: 02/03/2019

Product: Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution (1002 mL)

Model:

NDC 42852-703-99

D-0498-2019

Lot Numbers:

12/14/18 1482 70399P

12/14/18 1610 70399P

Date Ranges: BUD: 02/27/19

Product: Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution (503 mL)

Model:

NDC 42852-706-50

D-0499-2019

Lot Numbers:

11/27/18 3177 70650P

11/27/18 6618 70650P

11/28/18 7716 70650P

12/31/18 5698 70650P

Date Ranges: BUD: 02/10/2019, BUD: 02/12/19, BUD: 03/16/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82089

Status: Resolved

Manufacturer: Advanced Pharma Inc.

Sold By: Avella of Houston

Manufactured In: United States

Units Affected: 3 products (12 bags; 672 bags; 1460 bottles)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected product by checking the labels for Oxytocin Injectable Solution from Avella of Houston with NDC numbers 42852-730-99, 42852-703-99, or 42852-706-50.

Check for Oxytocin 10 Units with Lot 12/20/18 1056 73099P (BUD: 02/03/2019).

Check for Oxytocin 20 Units with Lots 12/14/18 1482 70399P or 12/14/18 1610 70399P (BUD: 02/27/19).

Check for Oxytocin 30 Units with Lots 11/27/18 3177 70650P, 11/27/18 6618 70650P (BUD: 02/10/2019), 11/28/18 7716 70650P (BUD: 02/12/19), or 12/31/18 5698 70650P (BUD: 03/16/19).

Contact your healthcare provider or pharmacist immediately for guidance if you have been administered this product or have it in your inventory.

Return any unused product to the pharmacy or place of purchase for a refund.

Contact the manufacturer, Advanced Pharma Inc. (Avella of Houston), at 9265 Kirby Dr, Houston, Texas, 77054-2520 for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution (1001 mL)

Model:

NDC 42852-730-99

D-0497-2019

Lot Numbers:

12/20/18 1056 73099P

Date Ranges: BUD: 02/03/2019

Product: Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution (1002 mL)

Model:

NDC 42852-703-99

D-0498-2019

Lot Numbers:

12/14/18 1482 70399P

12/14/18 1610 70399P

Date Ranges: BUD: 02/27/19

Product: Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution (503 mL)

Model:

NDC 42852-706-50

D-0499-2019

Lot Numbers:

11/27/18 3177 70650P

11/27/18 6618 70650P

11/28/18 7716 70650P

12/31/18 5698 70650P

Date Ranges: BUD: 02/10/2019, BUD: 02/12/19, BUD: 03/16/19