Based out of largest city in the US Columbus, Ohio – Amerisource Health Services (a subsidiary of AmerisourceBergen Corporation) – offers unit doses, generic bottles, and robot pouches, as well as bar coded pouched products that support pharmacy robotics, provides brand and generic products for health systems and retail pharmacies.
BluePoint Laboratories – the company for whom Zydus Cadila manufactured the product provides high-quality generic drugs at competitive prices, while ensuring a safe and secure supply chain. It purchases drugs directly from FDA approved manufacturers and manages a robust market monitoring system in order to keep prices competitive.
Zydus Cadila (Cadila HealthCare) is the manufacturer of the product, BluePoint Laboratories is the company for whom Cadila manufactured the product and Amerisource Health Services is the distributor of the manufactured product in the United States.
Zydus Cadila had received the approval from US FDA for the product Bupropion Hydrochloride – anti-depressants tablets in January, 2014.
This is the second recall for the product in a span of 4 months. The first recall initiated on 4-Aug-16 was for 2,626 bottles of 500-count each. The tablets had then failed dissolution specifications during the 3 month stability testing period.
The second recall initiated last month is for 20,537 bottles i.e. 15,409 bottles of 90-count each and 5,128 bottles of 500-count each. While the first recall was due to the failure during the 3 month stability testing period, this recall was due to the failure during a 6 month stability testing period. The lots affected have an expiry of March and April, 2018.
Both the recalls were classified as Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. Stability testing permits the establishment of recommended storage conditions, retest periods, and shelf lives.