FDA-Drug2021-03-24Class II
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
Breckenridge Pharmaceutical, Inc
Hazard
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Sold states
Product was distributed nationwide
Affected count
3,146 bottles
Manufactured in
15 Massirio Dr Ste 201, N/A, Berlin, CT, United States
Products
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0308-2021Don't want to check this manually?
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