Home / Recalls / American Pharmaceutical Ingredients LLC / D-0529-2018

D-0529-2018 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
63975 g

Product Description

Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), 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) UT2140602-1132014, Exp. 05/31/2019; b) UT2140602-1142014, UT2140602-4222015, Exp. 05/31/2019; UT2140602-10292014, Exp. 05/31/02019; UT2131205UI-1192015, Exp.11/30/2018; UT2140602-10292014, Exp. 05/31/2019; c) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, Exp. 11/30/2018; UT2140602-4222015, Exp. 5/31/2019; d) UT2140602-10282014, Exp. 05/31/2019; UT2131205UI, UT2131205UI-1192015, Exp. 11/30/2018.

Other recalls by American Pharmaceutical Ingredients LLC

  • D-0591-2018 Class II — Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58 (March 7, 2018)
  • D-0592-2018 Class II — Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC (March 7, 2018)
  • D-0509-2018 Class II — Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by Am (February 9, 2018)
  • D-0533-2018 Class II — Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (February 9, 2018)
  • D-0482-2018 Class II — Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-821 (February 9, 2018)
  • D-0496-2018 Class II — Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1) (February 9, 2018)
  • D-0513-2018 Class II — Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025- (February 9, 2018)
  • D-0500-2018 Class II — Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (ND (February 9, 2018)
  • D-0489-2018 Class II — Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packa (February 9, 2018)
  • D-0511-2018 Class II — Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g ( (February 9, 2018)