Reported Sep 4, 2019 · Terminated
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810…
Aurobindo Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Simvastatin Tablets, USP 40 mg. Rx
- Only 1000 Count Bottles Manufactured byAurolife Pharma
- LLC Dayton NJ 08810 Manufactured forAurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
- Lot codes and dates
05318054Bexp 3/2021
- Amount recalled
- 2,352/1000 count bottles
Where it was sold
- Nationwide
Why it was recalled
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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