Recalls / Class II
Class IID-983-2014
Product
GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.
- Affected lot / code info
- GLYCOPYRROLATE, Tablet, 2 mg has the following codes: Pedigree: W002650, 6/5/2014; Pedigree: W003252, 6/17/2014; Pedigree: AD22865_4, 5/2/2014.
Why it was recalled
Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014; LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 1300 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-983-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.