Recalls / Class II
Class IID-0065-2018
Product
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
- Affected lot / code info
- Lot: 20170912@13 BUD: 10/22/2017
Why it was recalled
Lack Of Assurance Of Sterility.
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, N/A, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 450 bags
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2017-10-19
- FDA classified
- 2017-11-02
- Posted by FDA
- 2017-11-08
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0065-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.