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Class II · ModerateRecall completed

Omeprazole 4 mg/mL Suspension

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

Does this affect you?
Check your lot numberN/A
Where it was soldTN only
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

Lack of Processing Controls.

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 / forDuren Health Mart Pharmacy
NDC00000-0001-07
Show the full FDA record
Full product labelOmeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07
Recalling firmDuren Health Mart Pharmacy
DistributionTN only
Quantity2700 cc
Recall initiated2018-12-17
Report date2019-02-06
Recall completed2022-01-19
Recall numberD-0416-2019
ClassificationClass II
FDA statusTerminated
Origin on fileWaynesboro TN United States

Related

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.