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Class II: temporary or reversible health riskTerminated

Milbar Laboratories DCL AHA Lightening Gel Recall

DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl

Milbar Laboratories, Inc. · East Haven, CT

Risk level
Class II
Reported by FDA
Nov 25, 2020
Recall ID
D-0085-2021
Check your lot numberHow we source this data

Summary

Milbar Laboratories recalled DCL AHA Lightening Gel starting Oct 9, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0085-2021 on Nov 25, 2020. Reason: GMP Deviations. Status: Terminated.

Why it was recalled

GMP Deviations

Product description

DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471

Lot numbers, UPCs & expiration codes

Lot #: LW110-3, Exp. Date Nov-22

Where it was sold

Product was distributed throughout the United States, including Puerto Rico and internationally.

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-0085-2021
Classification
Class II
Status
Terminated
Recall initiated
Oct 9, 2020
FDA report date
Nov 25, 2020
Quantity
1,608 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Milbar Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0085-2021, exactly as published.

Show all FDA fields
City
East Haven
State
CT
Status
Terminated
Country
United States
Event ID
86579
Address
20 Commerce St
Code information
Lot #: LW110-3, Exp. Date Nov-22
Postal code
06512-4145
Report date
Nov 25, 2020
Product type
Drugs
Recall number
D-0085-2021
Classification
Class II
Recalling firm
Milbar Laboratories, Inc.
Product quantity
1,608 bottles
Termination date
Jan 4, 2023
Reason for recall
GMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
Distribution pattern
Product was distributed throughout the United States, including Puerto Rico and internationally.
Recall initiation date
Oct 9, 2020
Initial firm notification
Letter
Center classification date
Nov 17, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0085-2021, published Nov 25, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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