FDA-Drug2014-01-22Class II

PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510

Aidapak Services, LLC
Hazard

Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.

Sold states
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Affected count
100 Tablets
Manufactured in
14301 Se 1st St, Vancouver, WA, United States
Products
PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-718-2014

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