Class II · ModerateRecall completed
MONTELUKAST SODIUM
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberMONTELUKAST SODIUM, CHEW Tablet, 4 mg has the following codes: Pedigree: AD76639_11, EXP: 5/31/2014.
Where it was soldRepacked drugs were distributed in Arizona, California, Oregon, and Washington.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | AidaPak Service, LLC |
| NDC | 00006071131 |
Show the full FDA record
| Full product label | MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131. |
| Recalling firm | Aidapak Services, LLC |
| Distribution | Repacked drugs were distributed in Arizona, California, Oregon, and Washington. |
| Quantity | 30 CHEW Tablets |
| Recall initiated | 2013-07-02 |
| Report date | 2014-01-29 |
| Recall completed | 2014-02-07 |
| Recall number | D-776-2014 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Vancouver WA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.