Recalls / Class II
Class IID-1394-2019
Product
Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.
- Brand name
- Anastrozole
- Generic name
- Anastrozole
- Active ingredient
- Anastrozole
- Route
- Oral
- NDC
- 60687-112
- FDA application
- ANDA078921
- Affected lot / code info
- Lot #: 175289A, 175286B, 175290B, Exp. 08/31/2019; 179906A, Exp. 03/31/2020; 183252A, Exp. 09/30/2020; 184611A, Exp. 11/30/2020
Why it was recalled
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 15,386 cartons
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2019-05-09
- FDA classified
- 2019-06-19
- Posted by FDA
- 2019-06-26
- Terminated
- 2020-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1394-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.