D-1338-2015 Class II Terminated
FDA drug recall D-1338-2015 was initiated by South Coast Specialty Compounding, Inc. on April 23, 2015 and is designated Class II. Reason for recall: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. The recall status is terminated (terminated May 31, 2016). Affected quantity: 2,355 capsules ( 26 presciptions).
Recall Details
- Product Type
- Drugs
- Report Date
- September 9, 2015
- Initiation Date
- April 23, 2015
- Termination Date
- May 31, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,355 capsules ( 26 presciptions)
Product Description
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 Pattern
Nationwide.
Code Information
All Lots; Exp 06/15