Recalls / Class III
Class IIID-0120-2017
Product
Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
- Affected lot / code info
- Lot Numbers (a) 4101059, 4101062, 4190536, 4265205, 4359294, 4501265, 4572326, 4651818, 4731571, 4798704 (b) 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4265203, 4265204, 4359296, 4367922, 4379814, 4403535, 4403536, 4501267, 4506357, 4563352, 4563353, 4572327, 4572328, 4627845, 4731572, 4731573, 4798705, 4936585
Why it was recalled
Subpotent Drug; Ethinyl Estradiol
Recalling firm
- Firm
- Par Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 393,981 tablets
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-09-27
- FDA classified
- 2016-11-01
- Posted by FDA
- 2016-11-09
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0120-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.