FDA Drug recall D-0424-2017
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle,…
- FDA Drug
- Class III
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class III recall of Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle,… by Pfizer, citing failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0424-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-09 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34
Reason
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Identifiers
| ndc | 0025-1451-60 |
|---|---|
| ndc | 0025-1461-34 |
| ndc | 0025-1461-60 |
| ndc | 0025-1461-31 |
| code_info | 1) Lot # B08493 - Expiration Date 12/2016; 2) Lot # B13230 - Expiration Date 08/2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0424-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.