On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. The products that were recalled include:
- 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials
- 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials
- 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials
- 7 lots of Potassium Phosphates Injection, USP, 45 mM vials
In Hospira’s recall announcement, the company states that the products being recalled were distributed to healthcare facilities, but were not directly distributed to patients or consumers. However, the company notes that if any of the products in question were “administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.” Furthermore, while the possibility of a breach in sterility assurance in these products is very slim, it cannot be eliminated completely.
Following Hospira’s announcement, there have been a number of voluntary recalls regarding various lots of Potassium Phosphate & Succinylchoine Chloride.
Advanced Pharma Recalls Various Lots of Potassium Phosphate & Succinylchoine Chloride
On June 22, 2017, the FDA published an announcement stating that, Advanced Pharma, Inc. d/b/a Avella of Houston, is recalling specific lots of Potassium Phosphate and Succinylcholine Chloride, which is a secondary recall on Hospira’s recent announcement. According to the FDA, the products that Advanced Pharma is recalling were “repackaged and/or compounded at its Houston, Texas facility using certain Hospira products.”
Customers who could potentially be impacted by the voluntary recall are being notified by the company via phone, email, and overnight mail. Furthermore, FDA states that “customers in Arizona, California, Colorado, Delaware, Georgia, Louisiana, Nebraska, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Washington that have any of the affected medications that are being recalled should immediately discontinue use and return the unused portion to Avella Specialty Pharmacy.” Individuals with any of the medications in question can find additional information on the specific lot numbers affected, product images, forms, and contact information on Advanced Pharma’s website.
For additional information on Advanced Pharma’s voluntary recall, view FDA’s recent announcement.
Fagron Sterile Services Recalls its Succinylcholine Chloride 20mg/mL 5mL syringe
On June 23, 2017, Fagron Sterile Services announced that it is voluntarily recalling three lots of its Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. This is also secondary recall which is being conducted as a result of the recall recently initiated by Hospira. So far, FDA states that no adverse events have been reported and no microorganisms have been confirmed in any Fagron Sterile Services’ lot.
“Succinylcholine Chloride Injection is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is repacked by Fagron Sterile Services into 5mL doses of Succinylcholine Chloride 20mg/mL.” The impacted lots were distributed nationwide to hospitals and surgical clinics, and include the following:
| Lot Number |
Beyond-Use Date |
| C274-000000331 |
08/30/2017 |
| C274-000001274 |
09/07/2017 |
| C274-000001326 |
09/14/2017 |
Fagron Sterile Services has notified its direct customers by telephone and is in the process of arranging for return and replacement of all recalled products. FDA’s recent announcement states that “hospitals or surgical clinics that have received impacted product which is being recalled, should immediately examine stock and discontinue dispensing.”
For additional information on Fagron’s voluntary recall, view FDA’s recent announcement.
Potassium Phosphate and Succinylcholine Chloride Voluntarily Recalled by PharMEDium Services
In addition to Advanced Pharma and Fagron Sterile Services, on Monday, June 26, 2017, PharMEDium Services announced a voluntarily recall of specific lots of Potassium Phosphate and Succinylcholine Chloride. Like the previous recalls, PharMEDium's voluntary recall of these products is also a secondary recall based on Hospira's recent recall.
In a recent press release on the subject, FDA notes that "PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol." PharMEDium is providing additional information on its website for customers with any of the medications in question. This information includes the specific lot numbers that are being recalled as well as contact information.
Additional information on PharMEDium's voluntary recall can be found in the FDA's recent announcement.
Do you manufacture an FDA-regulated product? Do you want to avoid FDA action and ensure that you are compliant with all regulations and requirements? Our quality and compliance group can help with all of your GMP and GCP needs. To learn more about our services and how we can help you, contact us today.
