Banner Pharmacy Recalls Ropivacaine HCL Cassettes Due to Sterility Concerns
Banner Pharmacy Services is recalling Ropivacaine HCL cassettes because the FDA determined there is a lack of assurance of sterility.
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: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard of sterility failure in an injectable medication is significant.
Plain-English summary
Banner Pharmacy Services, LLC is recalling 2,173 cassettes of Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL. The product is a prescription-only medication manufactured by Banner Health Compounding Pharmacy in Chandler, Arizona.
The recall was initiated due to a lack of assurance of sterility. This means the FDA cannot guarantee that the medication is free from microbial contamination, which poses a risk of infection if administered to patients.
The affected lots were distributed nationwide within the US. Patients who have received this medication should contact their healthcare provider for guidance. The specific lot numbers and expiration dates are listed in the official recall documentation.
The recalled product
- Product
- Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
- Manufacturer
- Banner Pharmacy Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 2,173
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: 041117S2
- Exp 10/11/2017
- 041817S3
- Exp 10/18/2017
- 042517S3
- 10/25/2017
- 050117S2
- Exp 10/3102/17
- 053017S3
- Exp 11/29/2017
- 060117S3
- Exp 12/1/2017
- 060617S3
- Exp 12/6/2017
- 061217S1
- 12/12/2017
- 062017S3
- Exp 12/20/2017
- 062717S2
- Exp 12/27/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Banner Pharmacy Services, 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.
See all 14 products in this recall →Related recalls
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