Home / Recalls / American Pharmaceutical Ingredients LLC / D-0518-2018

D-0518-2018 Class II Terminated

Recalled by American Pharmaceutical Ingredients LLC — Waterford, MI

FDA drug recall D-0518-2018 was initiated by American Pharmaceutical Ingredients LLC on Feb 9, 2018 and is designated Class II. 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. The recall status is terminated (terminated Dec 2, 2019). Affected quantity: 1,050,000 g.

Recall Details

Product Type
Drugs
Report Date
Feb 28, 2018
Initiation Date
Feb 9, 2018
Termination Date
Dec 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,050,000 g

Product Description

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), 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) 031115-3, Exp. 12/24/2019; b) 031115-3, Exp. 12/24/2019 c) 031115-3, Exp. 12/24/2019; 050815-3, Exp. 04/14/2020; d) 010716-1, 010716-6, Exp. 11/10/2018; 030116-4, Exp. 12/04/2018; 031115-2, Exp. 12/24/2019; 060116-9, Exp. 4/28/2019; 080416-1, 080416-4, Exp. 06/05/2019; 080615-4, Exp. 07/29/2020; 112015-6, Exp. 10/7/2018; 121916-7, Exp. 11/10/2018; e) 080615-5, Exp. 07/29/2020; 010716-4, 010716-5, Exp. 11/10/2018; 030116-2, Exp. 12/04/2018; 031115-5, Exp. 12/24/2019; 060116-1, 060116-4, 060116-5, Exp. 04/28/2019; 080416-1, 080416-2, exp. 06/05/2019; 112015-1, Exp. 10/07/2018; 121916-2,121916-3, 121916-6, Exp. 11/02/2019; f) 112015-5, Exp. 10/07/2018; 010716-1, Exp. 11/10/2018; 030116-3, Exp. 12/04/2018; 010716-1, 010716-2, 010716-3, 010716-8, Exp. 11/10/2018; 030116-1, 030116-3, 030116-4,030116-5, Exp. 12/4/2018; 031115-5, Exp. 12/24/2019; 060116-4, 060116-6, 060116-8, 060116-9, Exp. 04/28/2019; 080416-3, 080416-4, 080416-5, Exp. 06/05/2019; 112015-2, 112015-3, 112015-4,112015-6, 112015-7, Exp. 10/07/2018; 121916-1, Exp. 11/02/2019; 121916-3, 121916-4, 121916-5, 121916-7 121916-8, Exp.11/02/2019; g) 060116-2, 060116-3 060116-7, Exp. 04/28/2019.

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0518-2018
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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  • D-0511-2018 Class II — Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g… (Feb 9, 2018)
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  • D-0481-2018 Class II — Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC… (Feb 9, 2018)
  • D-0533-2018 Class II — Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g… (Feb 9, 2018)
  • D-0510-2018 Class II — Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000… (Feb 9, 2018)
  • D-0500-2018 Class II — Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g… (Feb 9, 2018)
  • D-0513-2018 Class II — Nifedipine USP for prescription compounding, packaged in a) 5g (NDC… (Feb 9, 2018)
  • D-0489-2018 Class II — Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding… (Feb 9, 2018)

FDA data resources