Why it was recalled
Presence of foreign substance: metallic razor blade was found in one bottle.
Product description
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Lot numbers, UPCs & expiration codes
Lot #: E171280, Exp 06/19
Where it was sold
U.S.A. nationwide
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-0223-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 22, 2017
- FDA report date
- Jan 24, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs, Ltd. - Unit III
Original FDA data
Every field from FDA enforcement report D-0223-2018, exactly as published.
Show all FDA fields
- City
- Hyderabad
- Status
- Terminated
- Country
- India
- Event ID
- 78821
- Address
- Plot 22-110, Part Ii, Ida
- Address (line 2)
- Rangareddy, Jeedimetla
- Code information
- Lot #: E171280, Exp 06/19
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0223-2018
- Classification
- Class III
- Recalling firm
- Hetero Labs, Ltd. - Unit III
- Termination date
- Mar 23, 2018
- Reason for recall
- Presence of foreign substance: metallic razor blade was found in one bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
- Distribution pattern
- U.S.A. nationwide
- Recall initiation date
- Dec 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2018