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Class III · Lower riskRecall completed

Amoxicillin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numbera) NDC [redacted-phone] -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC [redacted-phone] -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.
Where it was soldNationwide
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

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

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

Made byTeva Pharmaceuticals USA, Inc.
Brand nameAMOXICILLIN
Generic nameAMOXICILLIN
Active ingredient(s)AMOXICILLIN
Distributed by / forTeva Pharmaceuticals USA, Inc.
NDC0093-4161-78
Show the full FDA record
Full product labelAmoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Recalling firmTeva Pharmaceuticals USA, Inc.
DistributionNationwide
Quantity758,554 bottles
Recall initiated2013-04-26
Report date2013-06-19
Recall completed2013-12-24
Recall numberD-598-2013
ClassificationClass III
FDA statusTerminated
Origin on fileSellersville PA 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.