Why it was recalled
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 175289A, 175286B, 175290B, Exp. 08/31/2019; 179906A, Exp. 03/31/2020; 183252A, Exp. 09/30/2020; 184611A, Exp. 11/30/2020
Where it was sold
Nationwide within the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1394-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 9, 2019
- FDA report date
- Jun 26, 2019
- Quantity
- 15,386 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1394-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 82854
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 175289A, 175286B, 175290B, Exp. 08/31/2019; 179906A, Exp. 03/31/2020; 183252A, Exp. 09/30/2020; 184611A, Exp. 11/30/2020
- Postal code
- 43217-1188
- Report date
- Jun 26, 2019
- Product type
- Drugs
- Recall number
- D-1394-2019
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 15,386 cartons
- Termination date
- Sep 30, 2020
- Reason for recall
- GMP Deviations: Potential cross contamination due to cleaning procedure failure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- May 9, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 19, 2019