Recalls / Class II
Class IID-783-2014
Product
PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032121201.
- Affected lot / code info
- PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units has the following codes: Pedigree: W003731, EXP: 6/26/2014; Pedigree: W002819, EXP: 6/7/2014; Pedigree: W002849; EXP: 6/7/2014; Pedigree: AD30180_4, EXP: 5/8/2014.
Why it was recalled
Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003726, EXP: 6/26/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 54092025290, Pedigree: W002790, EXP: 6/6/2014; CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: W002844, EXP: 6/7/2014; AT
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 400 Capsules
- 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-783-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.