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Class III: unlikely to cause harmTerminated

Biocon Simvastatin Tablets Recall

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 coun…

Biocon Inc · Iselin, NJ

Risk level
Class III
Reported by FDA
Apr 20, 2016
Recall ID
D-0817-2016
Check your lot numberHow we source this data

Summary

Biocon recalled Simvastatin Tablets starting Mar 24, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0817-2016 on Apr 20, 2016. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134

Lot numbers, UPCs & expiration codes

Lot # 14S0042F5B, exp. 4/2016

Where it was sold

PA, CA, & OH

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0817-2016
Classification
Class III
Status
Terminated
Recall initiated
Mar 24, 2016
FDA report date
Apr 20, 2016
Quantity
5505 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Biocon Inc

Original FDA data

Every field from FDA enforcement report D-0817-2016, exactly as published.

Show all FDA fields
City
Iselin
State
NJ
Status
Terminated
Country
United States
Event ID
73699
Address
485 US Highway 1 S Ste B305
Code information
Lot # 14S0042F5B, exp. 4/2016
Postal code
08830-3009
Report date
Apr 20, 2016
Product type
Drugs
Recall number
D-0817-2016
Classification
Class III
Recalling firm
Biocon Inc
Product quantity
5505 bottles
Termination date
Dec 4, 2017
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
Distribution pattern
PA, CA, & OH
Recall initiation date
Mar 24, 2016
Initial firm notification
Letter
Center classification date
Apr 8, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0817-2016, published Apr 20, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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