January 2022 FDA Recall Drug by Teva Pharmaceuticals Usa (D-0520-2022 - Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.)
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on January 10, 2022 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications; low out of specification (oos) results for dissolution.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0520-2022
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
01-10-2022
02-09-2022
1,175 Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
nationwide in the USA
12-21-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Batch or Lot Expiration Information
Lot# : 100022970, Exp. 08/2022
