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Class II: temporary or reversible health riskTerminated

The Harvard Drug Group Fluconazole Tablets Recall

Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr

The Harvard Drug Group · Livonia, MI

Risk level
Class II
Reported by FDA
May 10, 2017
Recall ID
D-0688-2017
Check your lot numberHow we source this data

Summary

The Harvard Drug Group recalled Fluconazole Tablets starting Jan 5, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0688-2017 on May 10, 2017. Reason: Failed Dissolution Specifications. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications

Product description

Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61

Lot numbers, UPCs & expiration codes

Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17

Where it was sold

Nationwide within the US

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-0688-2017
Classification
Class II
Status
Terminated
Recall initiated
Jan 5, 2017
FDA report date
May 10, 2017
Quantity
2,341 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
The Harvard Drug Group

Original FDA data

Every field from FDA enforcement report D-0688-2017, exactly as published.

Show all FDA fields
City
Livonia
State
MI
Status
Terminated
Country
United States
Event ID
77106
Address
17177 N Laurel Park Dr Ste 233
Code information
Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17
Postal code
48152-3951
Report date
May 10, 2017
Product type
Drugs
Recall number
D-0688-2017
Classification
Class II
Recalling firm
The Harvard Drug Group
Product quantity
2,341 cartons
Termination date
Aug 4, 2017
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
Distribution pattern
Nationwide within the US
Recall initiation date
Jan 5, 2017
Initial firm notification
Letter
Center classification date
Apr 28, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0688-2017, published May 10, 2017. 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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