Recall archive
5 recalls · page 1 of 1
Reported Mar 21, 2018
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Pharmaceutical Ingredients LLC
Matched: Brand · Product · Product details — Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 28, 2018
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Pharmaceutical Ingredients LLC
Matched: Brand · Product details — CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
65 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 12, 2017
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Pharmaceutical Ingredients LLC
Matched: Brand · Product details — CGMP Deviations: Lack of quality assurance at the API manufacturer.
FDA (openFDA drug enforcement)
Reported Jul 5, 2017
Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Pharmaceutical Ingredients LLC
Matched: Brand · Product · Product details · Reason for recall — Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical…
FDA (openFDA drug enforcement)
Reported Jun 21, 2017
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Pharmaceutical Ingredients LLC
Matched: Brand · Product details — cGMP Deviations; lack of quality assurance.
FDA (openFDA drug enforcement)
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