Recalls / Class II
Class IID-0594-2018
Product
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
- Brand name
- Aripiprazole
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 31722-819, 31722-820, 31722-827, 31722-828, 31722-829, 31722-830
- FDA application
- ANDA205064
- Affected lot / code info
- Lot #: ARI17089, ARI17090, Exp. 5/2019
Why it was recalled
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
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
- 3000 bottles
- Distribution pattern
- NJ Only
Timeline
- Recall initiated
- 2018-01-10
- FDA classified
- 2018-03-13
- Posted by FDA
- 2018-02-14
- Terminated
- 2020-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0594-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.