Recalls / Class II
Class IID-0099-2018
Product
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47
- Brand name
- Levetiracetam
- Generic name
- Levetiracetam Oral
- Active ingredient
- Levetiracetam
- Route
- Oral
- NDC
- 31722-574
- FDA application
- ANDA203052
- Affected lot / code info
- Lot # E170346, Exp 02/19
Why it was recalled
Presence of foreign substance (screw)
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
- 4050 bottles
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2017-10-12
- FDA classified
- 2017-11-29
- Posted by FDA
- 2017-12-06
- Terminated
- 2020-09-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0099-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.