Class II Terminated

Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Company: American Pharmaceutical Ingredients Llc
Recall Initiated: February 9, 2018
Posted: February 28, 2018
Recall Number: D-0481-2018
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 123900 g
Firm Location: Waterford, MI, United States

Reason for Recall

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

Distribution

Nationwide within USA.

Lot / Code Info

Lot #: a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020;

More recalls by American Pharmaceutical Ingredients Llc

Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10...

Mar 21, 2018 · Class II

Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 5859...

Jul 12, 2017 · Class II

Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (...

Jul 5, 2017 · Class II

ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g...

Jun 21, 2017 · Class II

View all recalls by this company →

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