dilTIAZem HCl in Dextrose Injection Recalled for Sterility Assurance
SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile injectable drug with lack of assurance of sterility. Injectable medications require absolute sterility assurance, and failure to maintain sterile conditions poses significant risk of serious infection and potential hospitalization. Class II recalls of injectable products with sterility concerns meet the Severe threshold.
Plain-English summary
SterRx, LLC is recalling dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL (32 mcg per mL), due to lack of assurance of sterility. The affected product is distributed nationwide in the United States.
The recall involves 8,946 bags with various lot codes and expiration dates ranging from November 2021 to February 2022. The product is supplied under NDC 70324-951-01 and is manufactured by SterRx, LLC, located at 141 Idaho Ave., Plattsburgh, NY 12903.
Consumers and healthcare providers in possession of affected units should discontinue use immediately and contact their healthcare provider or pharmacist for guidance on replacement therapy or proper disposal instructions.
The recalled product
- Product
- dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
- Manufacturer
- SterRx, LLC
- Affected units
- 8,946
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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