Home / Recalls / American Pharmaceutical Ingredients LLC / D-0527-2018

D-0527-2018 Class II Terminated

Recalled by American Pharmaceutical Ingredients LLC — Waterford, MI

Recall Details

Product Type
Drugs
Report Date
February 28, 2018
Initiation Date
February 9, 2018
Termination Date
December 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47500 g

Product Description

Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

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 Pattern

Nationwide within USA.

Code Information

Lot #: a) 042016-2, Exp. 4/6/2019; b) 041217-1, Exp. 02/09/2019; 042016-2, 042016-3, Exp. 4/6/2019; c) 041217-1, 041217-3, Exp. 02/09/2019; 042016-1, Exp. 04/06/2019; 042016-2, Exp. 4/6/2019; d) 041217-3, Exp. 01/09/2019; 042016-1, Exp. 4/6/2019.

Other recalls by American Pharmaceutical Ingredients LLC

  • D-0592-2018 Class II — Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC (March 7, 2018)
  • D-0591-2018 Class II — Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58 (March 7, 2018)
  • D-0509-2018 Class II — Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by Am (February 9, 2018)
  • D-0480-2018 Class II — Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-801 (February 9, 2018)
  • D-0533-2018 Class II — Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (February 9, 2018)
  • D-0511-2018 Class II — Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g ( (February 9, 2018)
  • D-0498-2018 Class II — Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-833 (February 9, 2018)
  • D-0525-2018 Class II — Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) (February 9, 2018)
  • D-0482-2018 Class II — Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-821 (February 9, 2018)
  • D-0481-2018 Class II — Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58 (February 9, 2018)