Pallimed Solutions Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
Pallimed Solutions is recalling Bacteriostatic Water for Injection because FDA inspections found quality control issues that impacted sterility assurance.
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. According to the rubric, an FDA Class II recall involving a significant risk to health (sterility assurance failure in an injectable product) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High due to the nature of the defect in a sterile product.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling Bacteriostatic Water for Injection. The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. These findings specifically impacted the assurance of sterility for the product.
The recall covers all lots of the product within their expiry dates. The distribution pattern for the affected product is nationwide. The source text does not specify the exact number of units recalled or specific lot numbers.
Consumers and healthcare providers should stop using the recalled Bacteriostatic Water for Injection. They should contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Injectable
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Pallimed Solutions 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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