Drug recall
ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India…
FDA recall event 82827 · Class II · Zydus Pharmaceuticals USA Inc
Key facts
| Event ID | 82827 |
|---|---|
| Recall numbers | D-1440-2019, D-1441-2019, D-1442-2019, D-1443-2019, D-1444-2019, D-1445-2019, D-1446-2019, D-1447-2019, D-1448-2019, D-1449-2019, D-1450-2019, D-1451-2019 and 2 more |
| Recalling firm | Zydus Pharmaceuticals USA Inc |
| Product type | Drugs |
| Products | ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06, 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…, MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18, MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11, MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01 and 9 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. |
| Initiation date | May 6, 2019 |
| Report date | Jun 26, 2019 |
| Termination date | Sep 16, 2021 |
| City | Pennington |
| State | NJ |
| Country | United States |
| FEI number | 3008444937 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: