Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Presence of Ralstonia pickettii micro organism

Company Name:

(*60*)Taro Pharmaceuticals USA, Inc.

Brand Name:
Product Description:

Company Announcement

FOR IMMEDIATE RELEASE – Hawthorne, NY, December 27, 2021 ─ Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the buyer degree. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No different heaps of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii micro organism (“R. pickettii”), which was found by the producer by way of routine testing.

R. pickettii is current within the pure setting (soil, water) and for wholesome people with intact pores and skin, is unlikely to trigger any localized or systemic infections. However, for people who’re immunocompromised, or whose pores and skin just isn’t intact (i.e. sunburn, psoriasis, abrasions), there’s a cheap chance that systemic infections might happen if the product is contaminated with R. pickettii due to the presence of the corticosteroid part which boosts absorption of the ointment. If this bacterium is circulating within the human blood stream it could actually trigger life-threatening, invasive infections such sepsis, pneumonia, meningitis, irritation of the bone or bone marrow, and an infection within the joint fluid and joint tissues. To date, Taro has not acquired any opposed occasion experiences associated to this lot.

The one (1) lot being recalled is as follows:

Lot # Amount Expiration Date
AC13786 96 models December 2022

Clobetasol Propionate Ointment USP, 0.05% is indicated for the aid of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses and is packaged in 60 g aluminum tubes with polypropylene puncture-tip caps. Each 60 g tube is labeled to point out the title of the product, Clobetasol Propionate Ointment USP, 0.05% and the NDC # 51672-1259-3 (see picture of container label beneath). The Lot Number and Expiration Date are displayed on the underside of every tube and the tip flap of the product carton.

Ninety-six (96) models of Lot AC13786 have been distributed to two wholesale distributors within the U.S. market between November 16 and December 6, 2021. These two wholesale distributors might have additional distributed this lot to their retail clients for prescription meting out to sufferers who have been prescribed Clobetasol Propionate Ointment USP, 0.05%, 60 g.

Taro has notified the affected distributors by telephone, e-mail, and letters by way of U.S. Mail and is arranging for return of any containers of Clobetasol Propionate Ointment USP, 0.05%, 60 g, Lot AC13786 (expiration date of December 2022). Retail clients which have any portions of Lot AC13786 which is being recalled, ought to cease distribution and return any unsold models to their wholesaler.

Consumers with questions relating to this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday by way of Friday between 7:00 am and seven:00 pm, U.S. Central Time. Consumers ought to contact their doctor or healthcare supplier if they’ve skilled any issues which may be associated to taking or utilizing this drug product.

Adverse reactions or high quality issues skilled with the use of this product could also be reported to the FDA’s MedWatch Adverse Event Reporting program both on-line, by common mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download type or name 1- 800-332-1088 to request a reporting type, then full and return to the deal with on the pre-addressed type, or submit by fax to 1-800-FDA-0178

This recall is being performed with the information of the U.S. Food and Drug Administration.

SAFE HARBOR STATEMENT

Certain statements on this announcement are forward-looking statements throughout the that means of the Private Securities Litigation Reform Act of 1995. These statements embody, however usually are not restricted to, statements that don’t describe historic info or that refer or relate to occasions or circumstances the Company “estimates,” “believes,” or “expects” to occur or related language, and statements with respect to the voluntary recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g. Although the Company believes the expectations mirrored in such forward- wanting statements to be based mostly on cheap assumptions, it can provide no assurances that its expectations might be attained. Further updates, if applicable, might be detailed from time to time within the Company’s SEC experiences, together with its Annual Reports on Form 20-F. Forward-looking statements are relevant solely as of the date on which they’re made.


Company Contact Information

Consumers:
Taro Pharmaceuticals U.S.A., Medical Information


Product Photos