April 2020 FDA Recall Drug by B & B Pharmaceuticals, Inc.
D-1244-2020 - cGMP deviations

This Class II drug recall was voluntarily initiated by B & B Pharmaceuticals, Inc. on April 14, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1244-2020

Reason for Recall
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Initiated
04-14-2020
Reported
04-22-2020
Quantity
3,825 grams

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85440
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
B & B Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-24-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363