CLASS II Drug recall · Reported 17 Jul 2019 · FDA Enforcement Report
Anastrozole Tablets, USP, 1 mg, a) recalled by American Health Packaging
American Health Packaging is recalling Anastrozole Tablets, USP, 1 mg, a) (, distributed nationwide in the US. The recall was initiated on 9 May 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1467-2019
- FDA event ID
- 83290
- Recalling firm
- American Health Packaging, Columbus, OH
- Brand
- Anastrozole
- Manufacturer
- BluePoint Laboratories
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2019
- FDA classified
- 10 Jul 2019
- Reported
- 17 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Drug class
- Cancer Medication
Timeline
| 9 May 2019 | Recall initiated by company | |
| 10 Jul 2019 | Classified by FDA | +62 days |
| 17 Jul 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Which lots are affected?
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
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Health Packaging
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|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg (10 recalledMetoclopramide | American Health Packaging | Packaging Defects | Nationwide |
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| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
Other Anastrozole recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Anastrozole/Testosterone Cypionate/Propionate recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Anastrozole Tablets, 1 mg recalled by Zydus Pharmaceuticals USAAnastrozole | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Anastrozole Tablets, USP, 1mg unit dose blisters recalledAnastrozole | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Anastrozole Tablets, USP, 1 mg recalled by Zydus Pharmaceuticals USAAnastrozole | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology recalled | KRS Global Biotechnology | Other | Nationwide |