FDA approved vs. Pharmacy compounded 17-OHPC—current issues for obstetricians to consider in reducing recurrent preterm birth

Figures & data

Figure 1. Timeline of events in the development and approval of Makena.

Table 1. Recalls of compounded 17-OHPC.

Date	State	Reason for Recall
15 January 2016	CA	Lack of assurance of sterility
19 October 2015	AZ	Lack of assurance of sterility
9 September 2015	AL	Lack of assurance of sterility: possible contamination
3 September 2015	IL	Lack of assurance of sterility: observations associated with poor sterile production practices
24 July 2015	WA	Material or supplies were not disinfected prior to entering the aseptic processing areas
26 June 2015	OK	Lack of assurance of sterility: lack of documentation of proper environmental monitoring
15 June 2015	NJ	Lack of assurance of sterility: process deficiencies were observed in the production of sterile ophthalmic and injectable products
2 June 2015	TN	Lack of assurance of sterility: FDA inspection identified violations potentially impacting product quality and sterility
20 May 2015	NC	Lack of assurance of sterility and stability data does not support expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance
18 May 2015	CA	Use of a non-pharmaceutical grade component in the formulation of a drug product
31 December 2014	KY	Lack of assurance of sterility
9 October 2014	OR	Lack of sterility assurance: concerns associated with quality control procedures observed during an FDA inspection
3 October 2014	AZ	Lack of stability: two lots that contained crystals (197 vials)
28 January 2014	VA	Lack of stability: two compounded syringes had crystal-like precipitate in the syringe
19 October 2013	MI	Lack of sterility assurance: all compounded human and veterinary products recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile
1 August 2013	MI	Lack of sterility assurance
24 May 2013	TN	Nationwide recall of all products due to adverse events in three lots of preservative-free methylprednisolone acetate (MPA). CDC and FDA identified bacteria and fungi species in unopened vials of preservative-free methylprednisolone acetate
6 May 2013	FL	Lack of sterility assurance: concerns associated with quality control procedures observed during an FDA inspection
22 April 2013	IN	Lack of sterility assurance: due to concerns associated with quality control processes observed during an FDA inspection
17 April 2013	FL	Lack of sterility assurance: concerns associated with quality control processes
5 April 2013	NV	Lack of sterility assurance: nationwide recall due to lack of sterility assurance and concerns associated with the quality control processes.
25 March 2013	MA	Filaments observed in vials of sterile compounded products
20 March 2013	GA	Lack of sterility assurance: nationwide recall
24 February 2013	MA	Particulate matter was discovered in two lots; Massachusetts health officials issued a Cease and Desist order and a notice of Quarantine against the pharmacy on 02/20/13 after possible contamination of vials, pending a state and federal investigation
6 October 2012	MA	Fungal meningitis outbreak
25 May 2012	FL	FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared