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Class II: temporary or reversible health riskTerminated

Kroger Specialty Pharmacy Albuterol 0 Recall

Albuterol 0

Kroger Specialty Pharmacy, Inc. · Vicksburg, MS

Risk level
Class II
Reported by FDA
May 16, 2018
Recall ID
D-0735-2018
Check your lot numberHow we source this data

Summary

Kroger Specialty Pharmacy recalled Albuterol 0 starting Apr 3, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0735-2018 on May 16, 2018. Reason: Lack of Processing Controls. Status: Terminated.

Why it was recalled

Lack of Processing Controls.

Product description

Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30

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-0735-2018
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-0735-2018, 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-0735-2018
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
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
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-0735-2018, 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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