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Class III: unlikely to cause harmTerminated

Fagron Zinc Oxide Paste 25% Recall

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc

Fagron, Inc · Saint Paul, MN

Risk level
Class III
Reported by FDA
May 10, 2017
Recall ID
D-0695-2017
Check your lot numberHow we source this data

Summary

Fagron recalled Zinc Oxide Paste 25% starting Apr 17, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0695-2017 on May 10, 2017. Reason: Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container. Status: Terminated.

Why it was recalled

Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.

Product description

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

Lot numbers, UPCs & expiration codes

Lot #: 17C01-U07-036096, Exp. 5/1/2020

Where it was sold

Nationwide within 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-0695-2017
Classification
Class III
Status
Terminated
Recall initiated
Apr 17, 2017
FDA report date
May 10, 2017
Recall type
Voluntary: Firm initiated
Recalling firm
Fagron, Inc

Original FDA data

Every field from FDA enforcement report D-0695-2017, exactly as published.

Show all FDA fields
City
Saint Paul
State
MN
Status
Terminated
Country
United States
Event ID
77018
Address
2400 Pilot Knob Rd
Code information
Lot #: 17C01-U07-036096, Exp. 5/1/2020
Postal code
55120-1118
Report date
May 10, 2017
Product type
Drugs
Recall number
D-0695-2017
Classification
Class III
Recalling firm
Fagron, Inc
Termination date
Aug 11, 2017
Reason for recall
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
Distribution pattern
Nationwide within US
Recall initiation date
Apr 17, 2017
Initial firm notification
Letter
Center classification date
May 3, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0695-2017, 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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