FDA recall D-1244-2020

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 for recall

cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2020-04-14

Report date

2020-04-22

Termination date

2020-07-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1244-2020