Waterford, MI, United States
American Pharmaceutical Ingredients LLC recalls
2 recalls recorded since 2018, most recently on 7 March 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 7 March 2018
- Terminated
- 2 December 2019
- Reason
- Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0591-2018, D-0592-2018
- Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
- Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
Terminated Class II Drugs
- Recall started
- 9 February 2018
- Terminated
- 2 December 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0513-2018, D-0477-2018, D-0526-2018, D-0476-2018, D-0481-2018, D-0524-2018, D-0488-2018, D-0487-2018, D-0519-2018, D-0529-2018, D-0514-2018, D-0489-2018 and 54 more
- Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredient
- Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Hi
- Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredient
- Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutica
- 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
- Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, pac
- Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, p
- Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- and 58 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.