Fludrocortisone Acetate Tablets recall
FDA recall D-0601-2024 · initiated Jun 28, 2024
Teva Pharmaceuticals USA, Inc recalled Fludrocortisone Acetate Tablets in Jun 2024 — an FDA Class II recall (D-0601-2024) because Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 116,144 bottles
Details
- Product
- Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Jun 28, 2024
- FDA report date
- Jul 24, 2024
Frequently asked
- Was Fludrocortisone Acetate Tablets recalled?
- Teva Pharmaceuticals USA, Inc recalled Fludrocortisone Acetate Tablets in Jun 2024 — an FDA Class II recall (D-0601-2024) because Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fludrocortisone Acetate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0601-2024 was: Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
- Is a recalled Fludrocortisone Acetate Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fludrocortisone Acetate Tablets are affected?
- Distributed: Nationwide in the USA and Puerto Rico. The recall covers these lots — Lot #s: CNSDH, Exp. 6/30/2024; CNWVM, CNWWH, Exp. 07/31/2024; CNXKW, CNXKY, CNXMB, CNXMH, Exp. 09/30/2024; CPBTP, CPBTV, Exp. 11/30/2024.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0601-2024.