D-816-2013 Class III Terminated
FDA drug recall D-816-2013 was initiated by Max Huber Research Labs, Inc. on June 27, 2013 and is designated Class III. Reason for recall: Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled The recall status is terminated (terminated May 18, 2018). Affected quantity: 49,845 tubes (total for all products).
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2013
- Initiation Date
- June 27, 2013
- Termination Date
- May 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49,845 tubes (total for all products)
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
Reason for Recall
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Distribution Pattern
Nationwide
Code Information
all lots currently in the market shipped before June 2013