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Class II: temporary or reversible health riskTerminated

Leiter's Compounding Placebo for Prednisolone Acetate 1% Recall

Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded b…

Leiter's Compounding · San Jose, CA

Risk level
Class II
Reported by FDA
Oct 19, 2016
Recall ID
D-0017-2017
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Summary

Leiter's Compounding recalled Placebo for Prednisolone Acetate 1% starting Sep 20, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0017-2017 on Oct 19, 2016. Reason: Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Product description

Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA

Lot numbers, UPCs & expiration codes

All unexpired lots; Expirations dates of 10/11/2016 to 01/16/2017

Where it was sold

Nationwide

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-0017-2017
Classification
Class II
Status
Terminated
Recall initiated
Sep 20, 2016
FDA report date
Oct 19, 2016
Quantity
76,315 total units, all products
Recall type
Voluntary: Firm initiated
Recalling firm
Leiter's Compounding

Original FDA data

Every field from FDA enforcement report D-0017-2017, exactly as published.

Show all FDA fields
City
San Jose
State
CA
Status
Terminated
Country
United States
Event ID
75230
Address
17 Great Oaks Blvd
Code information
All unexpired lots; Expirations dates of 10/11/2016 to 01/16/2017
Postal code
95119-1359
Report date
Oct 19, 2016
Product type
Drugs
Recall number
D-0017-2017
Classification
Class II
Recalling firm
Leiter's Compounding
Product quantity
76,315 total units, all products
Termination date
May 3, 2017
Reason for recall
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Voluntary / mandated
Voluntary: Firm initiated
Product description
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Distribution pattern
Nationwide
Recall initiation date
Sep 20, 2016
Initial firm notification
Letter
Center classification date
Oct 12, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0017-2017, published Oct 19, 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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