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
Reported: November 9, 2016 Initiated: September 27, 2016 #D-0123-2017
Product Description
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
Reason for Recall
Subpotent Drug; Ethinyl Estradiol
Details
- Recalling Firm
- Par Pharmaceutical, Inc.
- Units Affected
- 44,127 tablets
- Distribution
- Nationwide and Puerto Rico
- Location
- Chestnut Ridge, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Par Pharmaceutical, Inc.. Units affected: 44,127 tablets.
Why was this product recalled? ▼
Subpotent Drug; Ethinyl Estradiol
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 9, 2016. Severity: Low. Recall number: D-0123-2017.
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