July 2018 FDA Recall Indomethacin by Hetero Labs, Ltd. - Unit Iii
D-1019-2018 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Hetero Labs, Ltd. - Unit Iii on July 18, 2018 for the product Indomethacin. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1019-2018

Reason for Recall
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Initiated
07-18-2018
Reported
08-08-2018
Quantity
18,288 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80589
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-15-2021
Product Description About Product Description
Full technical description of the product.
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.

Batch or Lot Expiration Information

Lot# : E180315, Exp 12/19

Affected Packages Involved in this Recall

31722-542-30 Indomethacin
31722-542-01 Indomethacin
31722-542-05 Indomethacin
31722-542-10 Indomethacin
31722-543-30 Indomethacin
31722-543-01 Indomethacin
31722-543-05 Indomethacin
31722-543-10 Indomethacin