Recalls / Class II
Class IID-1019-2018
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.
- Brand name
- Indomethacin
- Generic name
- Indomethacin
- Active ingredient
- Indomethacin
- Route
- Oral
- NDCs
- 31722-542, 31722-543
- FDA application
- ANDA091240
- Affected lot / code info
- Lot #: E180315, Exp 12/19
Why it was recalled
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Recalling firm
- Firm
- Hetero Labs, Ltd. - Unit III
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot 22-110, Part Ii, Ida, Rangareddy, Jeedimetla, Hyderabad, N/A N/A, India
Distribution
- Quantity
- 18,288 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-07-18
- FDA classified
- 2018-07-27
- Posted by FDA
- 2018-08-08
- Terminated
- 2021-07-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1019-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.