Recalls / Class II
Class IID-1441-2019
Product
Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10
- Brand name
- Anastrozole
- Generic name
- Anastrozole
- Active ingredient
- Anastrozole
- Route
- Oral
- NDC
- 68382-209
- FDA application
- ANDA078921
- Affected lot / code info
- Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20
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
- 768 1000-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-1441-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.