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Class III · Lower riskRecall completed

Simvastatin

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

Does this affect you?
Check your lot numberLot #: E171280, Exp 06/19
Where it was soldU.S.A. nationwide
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

Presence of foreign substance: metallic razor blade was found in one bottle.

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 byHetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India foreign manufacturer
Brand nameSIMVASTATIN
Generic nameSIMVASTATIN
Active ingredient(s)SIMVASTATIN
Distributed by / forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854
NDC31722-513-10
Show the full FDA record
Full product labelSimvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Recalling firmHetero Labs, Ltd. - Unit III
DistributionU.S.A. nationwide
QuantityN/A
Recall initiated2017-12-22
Report date2018-01-24
Recall completed2018-03-23
Recall numberD-0223-2018
ClassificationClass III
FDA statusTerminated
Origin on fileHyderabad N/A India

Related

Recent 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.