Recalls / Class III
Class IIID-0223-2018
Product
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
- Brand name
- Simvastatin
- Generic name
- Simvastatin
- Active ingredient
- Simvastatin
- Route
- Oral
- NDCs
- 31722-510, 31722-511, 31722-512, 31722-513, 31722-514
- FDA application
- ANDA200895
- Affected lot / code info
- Lot #: E171280, Exp 06/19
Why it was recalled
Presence of foreign substance: metallic razor blade was found in one bottle.
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
- N/A
- Distribution pattern
- U.S.A. nationwide
Timeline
- Recall initiated
- 2017-12-22
- FDA classified
- 2018-01-16
- Posted by FDA
- 2018-01-24
- Terminated
- 2018-03-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0223-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.