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Class II · ModerateRecall completed

Duloxetine HCl USP for prescription compounding

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

Does this affect you?
Check your lot numberLot #: a) 061115-2, Exp. 05/31/2019; b) 061115-1, Exp. 5/31/2019;
Where it was soldNationwide within USA.
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

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

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 / forAmerican Pharmaceutical Ingredients LLC
NDC58597-8632-6
Show the full FDA record
Full product labelDuloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Recalling firmAmerican Pharmaceutical Ingredients LLC
DistributionNationwide within USA.
Quantity10000 g
Recall initiated2018-02-09
Report date2018-02-28
Recall completed2019-12-02
Recall numberD-0487-2018
ClassificationClass II
FDA statusTerminated
Origin on fileWaterford MI 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.