Drug product
sitaGLIPtin PHOSPHATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006011231.
D-774-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-774-2014
Official wording
Reason: Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62992_1, EXP: 5/23/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: W002860, EXP: 6/7/2014.
Code information: sitaGLIPtin PHOSPHATE, Tablet, 50 mg has the following codes: Pedigree: AD62829_11, EXP: 5/23/2014; Pedigree: W002824, EXP: 6/7/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mixup