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Class II: temporary or reversible health riskTerminated

Milbar Laboratories Solar Defense Sheer Sunscreen Broad Spectrum Recall

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7

Milbar Laboratories, Inc. · East Haven, CT

Risk level
Class II
Reported by FDA
May 23, 2018
Recall ID
D-0812-2018
Check your lot numberHow we source this data

Summary

Milbar Laboratories recalled Solar Defense Sheer Sunscreen Broad Spectrum starting May 4, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0812-2018 on May 23, 2018. Reason: GMP Deviations. Status: Terminated.

Why it was recalled

GMP Deviations

Product description

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128

Lot numbers, UPCs & expiration codes

Lot #: KU455-2, Exp. 11/09/2020; KU455-6, Exp.11/26/2020

Where it was sold

Within the United States and Puerto Rico

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-0812-2018
Classification
Class II
Status
Terminated
Recall initiated
May 4, 2018
FDA report date
May 23, 2018
Quantity
2,156 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Milbar Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0812-2018, exactly as published.

Show all FDA fields
City
East Haven
State
CT
Status
Terminated
Country
United States
Event ID
80042
Address
20 Commerce St
Code information
Lot #: KU455-2, Exp. 11/09/2020; KU455-6, Exp.11/26/2020
Postal code
06512-4145
Report date
May 23, 2018
Product type
Drugs
Recall number
D-0812-2018
Classification
Class II
Recalling firm
Milbar Laboratories, Inc.
Product quantity
2,156 tubes
Termination date
Jun 26, 2019
Reason for recall
GMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128
Distribution pattern
Within the United States and Puerto Rico
Recall initiation date
May 4, 2018
Initial firm notification
Letter
Center classification date
May 15, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0812-2018, 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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