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Class II · ModerateRecall completed

Amoxicillin for Oral Suspension USP

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

Does this affect you?
Check your lot numberLots: (a) Lot # 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021
Where it was soldNationwide in the USA and Puerto Rico
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

Subpotent Product: assay results for Amoxicillin were below the specification limits.

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 / forTeva Pharmaceuticals USA, INC. North Wales, PA 19454
NDC0093-4150-80
Show the full FDA record
Full product labelAmoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Recalling firmTeva Pharmaceuticals USA
DistributionNationwide in the USA and Puerto Rico
Quantity171,488 150 mL and 80 mL bottles
Recall initiated2019-04-12
Report date2019-04-24
Recall completed2020-07-08
Recall numberD-1205-2019
ClassificationClass II
FDA statusTerminated
Origin on fileNorth Wales PA United States

Related

Amoxicillin recallsRecent drug recallsCheck another medication

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.