Class III
Completed
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
This recall has been completed (originally issued November 9, 2016).
- Company
- Par Pharmaceutical, Inc.
- Recall Initiated
- September 27, 2016
- Posted
- November 9, 2016
- Recall Number
- D-0123-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 44,127 tablets
- Firm Location
- Chestnut Ridge, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug; Ethinyl Estradiol
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736
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