Why it was recalled
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Product description
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Lot numbers, UPCs & expiration codes
Lot #: FIN16002, Exp. 03/2018
Where it was sold
NJ only.
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-0453-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 29, 2016
- FDA report date
- Feb 8, 2017
- Quantity
- 20,412 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Drugs Ltd. - Unit 1
Original FDA data
Every field from FDA enforcement report D-0453-2017, exactly as published.
Show all FDA fields
- City
- Medak District
- Status
- Terminated
- Country
- India
- Event ID
- 76120
- Address
- Plot Nos. 213, 214, 255
- Address (line 2)
- Bonthapally Village, Jinnaram Mandal
- Code information
- Lot #: FIN16002, Exp. 03/2018
- Report date
- Feb 8, 2017
- Product type
- Drugs
- Recall number
- D-0453-2017
- Classification
- Class III
- Recalling firm
- Hetero Drugs Ltd. - Unit 1
- Product quantity
- 20,412 units
- Termination date
- Jul 11, 2017
- Reason for recall
- Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
- Distribution pattern
- NJ only.
- Recall initiation date
- Dec 29, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 31, 2017