Reported Jun 14, 2017 · Terminated
Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile…
Qualgen
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualgen · 14844 Bristol Park Blvd · Edmond, OK · 73013-1891
Is this the product you have?
Estradiol 6 mg pellet 99.5% Estradiol USP.5% Stearic Acid NF in 1 count12 countand 30 count bottlesSterile Office Use OnlyFor Subcutaneous Use Only Rx OnlyManufactured byQualgen 14844 Bristol Park Blvd. Edmond
- OK 73013 NDC69761-006-01
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot# C046 2 Exp. 03/15/18 Lot# C025 3 Exp. 08/23/17 Lot# B159 4 Exp. 12/28/17 Lot# B121 5 Exp. 10/10/17 Lot# B118 6 Exp. 10/17/17 Lot# B086 7 Exp. 08/29/17 Lot# B068 8 Exp. 07/11/17 Lot# B053 9 Exp. 06/14/17 Lot# B034 10 Exp. 04/26/17 - Amount recalled
- 4,815 pellets.
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP deviations- Lack of Quality Assurance
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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