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Class III: unlikely to cause harmTerminated

Boiron Calendula Cream Recall

Calendula Cream, calendula officinalis 1X HUS-10%, 2

Boiron Inc. · Newtown Square, PA

Risk level
Class III
Reported by FDA
May 23, 2018
Recall ID
D-0803-2018
Check your lot numberHow we source this data

Summary

Boiron recalled Calendula Cream starting Apr 13, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0803-2018 on May 23, 2018. Reason: Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%. Status: Terminated.

Why it was recalled

Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.

Product description

Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

Lot numbers, UPCs & expiration codes

Lot Numbers: M7090711, M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019

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-0803-2018
Classification
Class III
Status
Terminated
Recall initiated
Apr 13, 2018
FDA report date
May 23, 2018
Quantity
52,810 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Boiron Inc.

Original FDA data

Every field from FDA enforcement report D-0803-2018, exactly as published.

Show all FDA fields
City
Newtown Square
State
PA
Status
Terminated
Country
United States
Event ID
79846
Address
6 Campus Blvd
Code information
Lot Numbers: M7090711, M7090712, M7090713, M7090709, M7090807, Exp: 09/2019 and M7110589, Exp: 11/2019
Postal code
19073-3200
Report date
May 23, 2018
Product type
Drugs
Recall number
D-0803-2018
Classification
Class III
Recalling firm
Boiron Inc.
Product quantity
52,810 tubes
Termination date
Jan 8, 2020
Reason for recall
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Distribution pattern
Nationwide
Recall initiation date
Apr 13, 2018
Initial firm notification
Letter
Center classification date
May 11, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0803-2018, published May 23, 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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