Drug Enforcement D-649-2014

Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801
Product quantity
120 Tablets
Reason for recall
Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014.
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-649-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
MISOPROSTOL, Tablet, 200 mcg has the following codes Pedigree: AD21965_13, EXP: 5/1/2014; Pedigree: W003117, EXP: 6/13/2014.
More code info