Why it was recalled
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
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.
Lot numbers, UPCs & expiration codes
Lot #: E180315, Exp 12/19
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1019-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 18,288 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs, Ltd. - Unit III
Original FDA data
Every field from FDA enforcement report D-1019-2018, exactly as published.
Show all FDA fields
- City
- Hyderabad
- Status
- Terminated
- Country
- India
- Event ID
- 80589
- Address
- Plot 22-110, Part Ii, Ida
- Address (line 2)
- Rangareddy, Jeedimetla
- Code information
- Lot #: E180315, Exp 12/19
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1019-2018
- Classification
- Class II
- Recalling firm
- Hetero Labs, Ltd. - Unit III
- Product quantity
- 18,288 bottles
- Termination date
- Jul 15, 2021
- Reason for recall
- Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 27, 2018