Status
Terminated
Drug Enforcement D-695-2014
Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105
- Product quantity
- 100 Tablets
- Reason for recall
- Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location & Firm
- Recalling firm
- Aidapak Services, LLC
- Address
-
14301 Se 1st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-695-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- HYDROCORTISONE Tablet, 5 mg has the following codes Pedigree: W002966, EXP: 6/11/2014; Pedigree: W003046, EXP: 6/12/2014.
- More code info
- —