Amneal Pharmaceuticals of New York, LLC recall records

0 reported ongoing

11 records in this archive. Latest source date Mar 25, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, ...

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

Class IIIReported terminated

Distribution: Nationwide in the USA and PR

Official source for Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial ...
FDA drug enforcement

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

Class IIReported terminated

Distribution: Product was distributed nationwide within the United States

Official source for Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by:...

Reasons in these listed records

  • Failed Dissolution Specifications
  • Superpotent Drug: Due to overfilling of drug powder
  • Failed Impurities/Degradation Specifications: Out-of-specification test results.
  • Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

These examples come from this result page and are not a ranking of every recall reason.

Checking Amneal Pharmaceuticals of New York, LLC

Is there a recall on amneal pharmaceuticals of new york, llc right now?

This archive contains 11 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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