Sterility Problems Prompt Big Jump In Q3 Drug Unit Recalls

Stericycle Expert Solutions, a provider of recall management services, reported that the number of recalled drug units spiked 290 percent in the third quarter, the highest total of any quarter in more than five years, according to the company’s Q3 Recall Index released Tuesday. Overall, the index found that pharmaceutical recalls climbed 3 percent to 89 ― the highest number since the last quarter of 2014.

Sterility problems were cited as the chief cause of recalls in the period, accounting for 96.7 percent of all recalled units. Stericycle, which declines to discuss specific companies included in its data, said an unnamed pharmaceutical manufacturer was “largely” responsible for the high number of sterility unit recalls.

Pharmaceutical Processing in August reported that Bella Pharmaceuticals began a voluntary recall all lots of unexpired sterile drug products distributed from April 17, 2017 to Aug. 10, 2017 due to lack of sterility assurance. The recalled products, packaged in a syringe, vial, or eye dropper, were distributed to health care facilities nationwide. Bella reported at the time that it had not received any reports of adverse events.

The following products were affected by the Bella Pharmaceuticals recall, according to the U.S. Food and Drug Administration:
 

Lot	Expiration Date	Product Name	Container type	Units Distributed
070617GL	1/6/18	Glutathione 200mg/ml	30ml Vial	82units
070717MC	1/7/18	Methylcobalamin 1mg/ml	30ml Vial	30units
070717ML	1/718	Mannitol 20%	10ml Vial	10units
071217GAC	1/12/18	GAC	30ml vial	3 units
071217CC	10/12/18	Calcium chloride 10%	10ml vial	5 units
BPBC3080517	2/5/18	B-Complex	30ml vial	45 units
BPMC30072917	1/29/18	Methylcobalamin 10mg/ml	30ml vial	7 units
BPMC08517	2/5/18	Magnesium Chloride 200mg	30ml vial	5 units
BPLG08517	2/5/18	L-Glutamine 100mg	30ml vial	5 units
BPMIC30072917	1/29/18	MIC 25/50/50	30ml Vial	5 units
BPLG3508717	11/7/17	Lidocaine Gel 3.5%	15ml dropper	6 units
BPPTC08717	11/17/17	Phenylephrine2.5%/Tropicamide 1%	15ml dropper	6 units
BPSB8408717	11/7/17	Sodium Bicarbonate 8.4%	10ml vial	20 units
BPFS41717	4/1/18	Fluorescein Sodium	5ml vial	644 units
3141201	9/13/17	Avastin (Bevacizumab)	BD 30g ½ and 31g 5/16 syringe	30 units
3146966	9/20/17	Avastin (Bevacizumab)	BD 30g ½ and 31g 5/16 syringe	310 units
3160608	10/5/17	Avastin (Bevacizumab)	BD 30g ½ and 31g 5/16 syringe	784 units
3146966	11/1/17	Avastin (Bevacizumab)	BD 30g ½ and 31g 5/16 syringe	646 units

Other reported recalls for sterility issues in Q3 included all unexpired sterile drug syringes and IV bags by Cantrell Drug Co. in July. The recalled products had been deistributed between Feb. 16, 2017 and July 19, 2017 to health care facilities in all but four states. 

Medical Devices: Hard Times for Software

The medical device industry saw a decline in recalls, according to Stericycle, dropping 39 percent to 167 ― the lowest quarter since Q4 2011. Despite the steep drop, recalled units ticked up 1 percent to 68 million. The main reason, again, involved sterility issues, causing 89.4 percent of all medical device recalled units.

Software issues were the biggest cause of recalls at 24.6 percent, making it the top recall cause in the segment for the sixth quarter in a row.

About the Index

The Stericycle Recall Index aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA, and the USDA.

In addition to pharmaceutical and medical device recalls, the company issues quarterly informaton on recalls in the food & beverage, automotive, and consumer product industries. The full Q3 2017 Recall Index is available for download.

(Source: Stericycle Expert Solutions)