Recalls / Class II
Class IID-586-2014
Product
GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884006601
- Affected lot / code info
- GLYCOPYRROLATE, Tablet, 2 mg has the following code Pedigree: W003625, EXP: 6/25/2014.
Why it was recalled
Labeling: Label Mixup; GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003624, EXP: 1/31/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 100 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-586-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.