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Class II: temporary or reversible health riskTerminated

Kroger Specialty Pharmacy Capecitabine 150 mg Tablet NDC 00378-2511-91 Recall

Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply

Kroger Specialty Pharmacy, Inc. · Vicksburg, MS

Risk level
Class II
Reported by FDA
May 16, 2018
Recall ID
D-0790-2018
Check your lot numberHow we source this data

Summary

Kroger Specialty Pharmacy recalled Capecitabine 150 mg Tablet NDC 00378-2511-91 starting Apr 3, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0790-2018 on May 16, 2018. Reason: Lack of Processing Controls. Status: Terminated.

Why it was recalled

Lack of Processing Controls.

Product description

Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply

Lot numbers, UPCs & expiration codes

All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Where it was sold

MS, LA, AR, IL, FL

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-0790-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 3, 2018
FDA report date
May 16, 2018
Quantity
Unknown
Recall type
Voluntary: Firm initiated
Recalling firm
Kroger Specialty Pharmacy, Inc.

Original FDA data

Every field from FDA enforcement report D-0790-2018, exactly as published.

Show all FDA fields
City
Vicksburg
State
MS
Status
Terminated
Country
United States
Event ID
79748
Address
100 Pear Orchard Dr Ste A
Code information
All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Postal code
39180-7153
Report date
May 16, 2018
Product type
Drugs
Recall number
D-0790-2018
Classification
Class II
Recalling firm
Kroger Specialty Pharmacy, Inc.
Product quantity
Unknown
Termination date
May 7, 2020
Reason for recall
Lack of Processing Controls.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Distribution pattern
MS, LA, AR, IL, FL
Recall initiation date
Apr 3, 2018
Initial firm notification
Letter
Center classification date
May 10, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0790-2018, published May 16, 2018. 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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