Home / Recalls / American Pharmaceutical Ingredients LLC / D-0591-2018

D-0591-2018 Class II Terminated

Recalled by American Pharmaceutical Ingredients LLC — Waterford, MI

Recall Details

Product Type
Drugs
Report Date
March 21, 2018
Initiation Date
March 7, 2018
Termination Date
December 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21 g

Product Description

Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

Reason for Recall

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

Distribution Pattern

Nationwide in the USA.

Code Information

Lot 012517-1R

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-0509-2018 Class II — Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by Am (February 9, 2018)
  • D-0500-2018 Class II — Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (ND (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-0511-2018 Class II — Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g ( (February 9, 2018)
  • D-0513-2018 Class II — Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025- (February 9, 2018)
  • D-0489-2018 Class II — Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packa (February 9, 2018)
  • D-0480-2018 Class II — Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-801 (February 9, 2018)