Recalls / Class III
Class IIID-0499-2019
Product
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.
- Affected lot / code info
- Lots: 11/27/18 3177 70650P, BUD: 02/10/2019; 11/27/18 6618 70650P, BUD: 02/10/2019; 11/28/18 7716 70650P, BUD: 02/12/19; 12/31/18 5698 70650P, BUD: 03/16/19
Why it was recalled
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 1460 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-02-06
- FDA classified
- 2019-02-15
- Posted by FDA
- 2019-02-27
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0499-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.