Recalling firm
Ecometics, Inc.
Product type
Drug
Status
Completed
Report date
2023-08-30
Distribution
Nationwide in the USA
Firm state
CT
Product quantity
a) 6,120 tubes, b) 540 tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Product description
Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.
Code / lot info
a) and b) 1E113A, exp 4/24
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.