FDA recall D-1338-2015
South Coast Specialty Compounding, Inc. · Class II · drug
Product
Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason for recall
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Distribution
Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2015-04-23
- Report date
- 2015-09-09
- Termination date
- 2016-05-31
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Irvine, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1338-2015