Recalls / Class II
Class IID-1440-2019
Product
ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06
- Brand name
- Anastrozole
- Generic name
- Anastrozole
- Active ingredient
- Anastrozole
- Route
- Oral
- NDC
- 68382-209
- FDA application
- ANDA078921
- Affected lot / code info
- Lot: M706674, M706676, M707685 EXP Jun-19; M711219, M711220, M711221, M711222, M711269, EXP Sep-19; M801027, EXP Dec-19; M801028, M801029, M801030, EXP Jan-20; M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20; M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957, M805958, M805959 Apr-20; M812457, EXP Jul-20, M812458, M812459, M813912, M813913, M813914, M813915, M813916, EXP Aug-20; M815768, M815769, M818274, EXP Oct-20; M818119, M818120, M818121, M818635, EXP Nov-20; M819270, M819861, M819862, EXP Dec-20; M900921, M900922, M900923, M900924, M900925, EXP Jan-21; M902634, M902635, EXP Feb-21.
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 1,425,264 30-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-06
- FDA classified
- 2019-07-01
- Posted by FDA
- 2019-06-26
- Terminated
- 2021-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1440-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.