Drug recall
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC…
FDA recall event 85440 · Class II · B & B Pharmaceuticals, Inc.
Key facts
| Event ID | 85440 |
|---|---|
| Recall numbers | D-1244-2020 |
| Recalling firm | B & B Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. |
| Initiation date | Apr 14, 2020 |
| Report date | Apr 22, 2020 |
| Termination date | Jul 24, 2020 |
| City | Englewood |
| State | CO |
| Country | United States |
| FEI number | 3000719772 |
At a glance
- 1–9 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: