Class II
Terminated
Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
This recall has been terminated (originally issued June 14, 2017).
- Company
- Qualgen
- Recall Initiated
- April 19, 2017
- Posted
- June 14, 2017
- Recall Number
- D-0895-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,260 pellets.
- Firm Location
- Edmond, OK, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviations- Lack of Quality Assurance
Distribution
Nationwide.
Lot / Code Info
Lot# C021; Exp. 08/20/17 Lot# B160, Exp. 12/29/17 Lot# B140; Exp. 11/15/17 Lot# B107; Exp. 09/29/17 Lot# B079; Exp. 08/15/17 Lot# B046; Exp. 06/01/17
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