Multi-event November 2023 FDA Recall Naproxen Sodium by Glenmark Pharmaceuticals Inc., Usa
This Multi-event Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on November 7, 2023 for the product Naproxen Sodium. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0123-2024
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
11-07-2023
12-06-2023
37,200 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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., 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
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01
Batch or Lot Expiration Information
Lot# 19231903; Exp 4/2025
Lot# 19231858; Exp 4/2025
Lot# 19231881; Exp 4/2025
Lot# 19233484; Exp 8/2025
Lot# 19233490; Exp 8/2025
Affected Packages Involved in this Recall
Recall Number: D-0124-2024
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
11-07-2023
12-06-2023
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., 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
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
Batch or Lot Expiration Information
Lot# 19231903; Exp 4/2025
Lot# 19231858; Exp 4/2025
Lot# 19231881; Exp 4/2025
Lot# 19233484: Exp 8/2025
Lot# 19233490; Exp 8/2025
