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.
Reported: August 8, 2018 Initiated: July 18, 2018 #D-1019-2018
Product Description
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.
Reason for Recall
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Details
- Recalling Firm
- Hetero Labs, Ltd. - Unit III
- Units Affected
- 18,288 bottles
- Distribution
- Nationwide in the USA
- Location
- Hyderabad, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hetero Labs, Ltd. - Unit III. Units affected: 18,288 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2018. Severity: Moderate. Recall number: D-1019-2018.
Related Recalls
FDA Drug Moderate
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…
Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…
Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…
Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical
Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC · 2026-02-11