Food, drugs, devices › American Pharmaceutical Ingredients LLC
Drug recall: ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8
American Pharmaceutical Ingredients LLC (Waterford, MI) initiated this drug recall on 17 Apr 2017; FDA lists 1 product record under event 77465, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 31 May 2018. Initiation: voluntary: firm initiated. American Pharmaceutical Ingredients LLC has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
American Pharmaceutical Ingredients LLC, Waterford, MI.
Reason for recall
"cGMP Deviations; lack of quality assurance."
Distribution
"NY, GA, NV, CA, KY, TX"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0919-2017 | ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327 | 1g=1 bottle; 5g=4 bottle; 25g=3 bottles | Class II | Terminated | 21 Jun 2017 |
Context
Other enforcement events for American Pharmaceutical Ingredients LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Mar 2018 | Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3 | Drug | Class II | 2 |
| 9 Feb 2018 | Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6) | Drug | Class II | 66 |
| 1 Jun 2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b | Drug | Class II | 1 |
| 26 May 2017 | Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 | Drug | Class II | 1 |
All 5 events for American Pharmaceutical Ingredients LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP Deviations; lack of quality assurance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "NY, GA, NV, CA, KY, TX"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 May 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.