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American Pharmaceutical Ingredients LLC

American Pharmaceutical Ingredients LLC Recalls

All product recalls associated with American Pharmaceutical Ingredients LLC.

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Recall Summary

Total Recalls

71

Past Year

0

Class I (Serious)

0

Most Recent

Mar 2018

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 71 recalls

Oxytocin Powder (American Pharmaceutical) – Unsupported Expiry (2018)

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Class IIModerate

FDAMar 7, 2018Nationwide• American Pharmaceutical Ingredients LLC

Sermorelin Acetate (American Pharmaceutical Ingredients) – Stability Issue (2018)

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

Class IIModerate

FDAMar 7, 2018Nationwide• American Pharmaceutical Ingredients LLC

Calcipotriene BP (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

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Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Estradiol USP Micronized (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Verapamil HCl USP (American Pharmaceutical) – Stability Verification Needed (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Tadalafil USP Monohydrate (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Tramadol HCl USP (American Pharmaceutical) – Stability Control Problems (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Nandrolone Decanoate USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Estradiol Hemihydrate USP (American Pharmaceutical) – Quality Control Gaps (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Doxycycline Hyclate USP (American Pharmaceutical) – Manufacturing Deviation (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Sildenafil Citrate USP (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Biotin USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Ketoconazole USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Methylcobalamin (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Nifedipine USP (American Pharmaceutical) – Stability Data Deficiency (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Tretinoin USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Cyanocobalamin USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Leucovorin Calcium USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Desoximetasone USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC

Stanozolol USP (American Pharmaceutical) - Stability Concerns (2018)

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Class IIModerate

FDAFeb 9, 2018Nationwide• American Pharmaceutical Ingredients LLC