Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

Class IIIReported terminated

Distribution: Nationwide USA

Official source

Apr 12, 2022FDA drug enforcement

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderaba...

Subpotent Drug: Out of specification for assay.

Class IIIReported terminated

Distribution: Alabama

Official source

Feb 22, 2022FDA drug enforcement

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus,...

Impurity failure at 0-time of the repackaged lot.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Dec 20, 2021FDA drug enforcement

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

Failed Dissolution Specifications

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Reasons in these listed records

Labeling: Label Mix-up
Failed dissolution
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Subpotent Drug: Out of specification for assay.

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

Checking American Health Packaging

Is there a recall on american health packaging right now?

This archive contains 6 records, including 1 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.

Records and reported status

Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individu...

Blue Point Laboratories: Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, D...

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderaba...

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus,...

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

Reasons in these listed records

Checking American Health Packaging

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