Why it was recalled
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Product description
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Lot numbers, UPCs & expiration codes
all lots currently in the market shipped before June 2013
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-816-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 27, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 49,845 tubes (total for all products)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Max Huber Research Labs, Inc.
Original FDA data
Every field from FDA enforcement report D-816-2013, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65629
- Address
- 767 Fifth Avenue
- Code information
- all lots currently in the market shipped before June 2013
- Postal code
- 10153
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-816-2013
- Classification
- Class III
- Recalling firm
- Max Huber Research Labs, Inc.
- Product quantity
- 49,845 tubes (total for all products)
- Termination date
- May 18, 2018
- Reason for recall
- Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 27, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 22, 2013