Recalls / Class III
Class IIID-0498-2019
Product
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.
- Affected lot / code info
- Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19
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
- 672 bags
- 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-0498-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.