Drug product
guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815
D-682-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 Tablets
- Official record key
drug-enforcement:D-682-2014
Official wording
Reason: Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216
Code information: guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21965_22, EXP: 5/1/2014; Pedigree: AD56917_13, EXP: 5/21/2014; Pedigree: AD73627_23, EXP: 5/30/2014; Pedigree: W003218, EXP: 6/17/2014; Pedigree: W003360, EXP: 6/19/2014; Pedigree: W002660, EXP: 6/5/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled