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Recall Observatory FDA recall evidence

Drug product

PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com.

D-1251-2020

March 03, 2020

Class II

Product summary

Firm
Yusef Manufacturing Laboratories, LLC
Event
Event 85323
Status
Terminated
Classification
Class II
Quantity
12,983 tubes
Official record key
drug-enforcement:D-1251-2020

Official wording

Reason: Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.

Code information: Lot #: 14381, Exp. Date 9/2023

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent