Recalls / Class II
Class IID-795-2014
Product
ACARBOSE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054014025.
- Affected lot / code info
- ACARBOSE, Tablet, 25 mg has the following codes: Pedigree: AD60272_1, EXP: 5/22/2014; Pedigree: W002725, EXP: 6/6/2014; Pedigree: W003673, EXP: 6/25/2014; Pedigree: W002996, EXP: 6/11/2014.
Why it was recalled
Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: AD60240_57, EXP: 5/22/2014; TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: W002724, EXP: 6/6/2014; SILDENAFIL CITRATE, Tablet, 25 mg, NDC 00069420030, Pedigree: W003646, EXP: 6/25/2014; SEVELAMER CARBONATE, Tab
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 399 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-795-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.