Recalls / Class II
Class IID-1467-2019
Product
Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories
- Brand name
- Anastrozole
- Generic name
- Anastrozole
- Active ingredient
- Anastrozole
- Route
- Oral
- NDC
- 68001-155
- FDA application
- ANDA078921
- Affected lot / code info
- Count, Lot, Expiry: [30-count bottle] Lots M711214, M711215, M711216, M711217, exp 8/31/2019; Lots M802198, M802199, exp 1/31/2020; Lots M805203, M805204, M805207, exp 3/31/2019; Lots M812455, exp 6/30/2020; Lot M815766, exp 9/30/2020; Lots M818633, M818634, exp 10/31/2020; Lots M819858, M819859, exp 11/30/2020 [1000-count bottle] Lot M711218, exp 8/31/2019; Lot M802197, exp 1/31/2020; Lots M805209, M805946, exp 3/31/2020; Lot M812456, exp 6/30/2020; Lots M815767, M818273, exp 9/30/2020; Lot M819857, exp 11/30/2020
Why it was recalled
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Recalling firm
- Firm
- American Health Packaging
- Manufacturer
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 375,921 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-05-09
- FDA classified
- 2019-07-10
- Posted by FDA
- 2019-07-17
- Terminated
- 2020-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1467-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.