FDA Drug recall D-1244-2020
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (…
- FDA Drug
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (… by B And B Pharmaceuticals, citing cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1244-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-14 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | B And B Pharmaceuticals |
| Distribution | US |
Product
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
Reason
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Identifiers
| code_info | Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1244-2020%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.