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Class II · ModerateRecall completed

OMEPRAZOLE/SODIUM BICARBONATE

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberOMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg has the following codes Pedigree: AD49399_4, EXP: 5/16/2014; Pedigree: AD46300_17, EXP: 5/15/2014; Pedigree: AD65457_22, EXP: 5/24/2014.
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; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forAidaPak Service, LLC
NDC11523726503
Show the full FDA record
Full product labelOMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
Recalling firmAidapak Services, LLC
DistributionRepacked drugs were distributed in Arizona, California, Oregon, and Washington.
Quantity294 Capsules
Recall initiated2013-07-02
Report date2014-01-22
Recall completed2014-02-07
Recall numberD-502-2014
ClassificationClass II
FDA statusTerminated
Origin on fileVancouver WA United States

Related

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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.