West-Ward Recalls Sodium Ferric Gluconate Injection Due to Low Iron Content
West-Ward Pharmaceuticals is recalling 5,142 shelf-packs of Sodium Ferric Gluconate Complex in Sucrose Injection because stability testing revealed the product had lower iron content than specified.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
West-Ward Pharmaceuticals Corp. is recalling 5,142 shelf-packs of Sodium Ferric Gluconate Complex in Sucrose Injection, 62.5mg elemental iron/5mL. The product is distributed nationwide in the United States. The specific lot number is 152032.1, with an expiration date of 2/2017.
The recall was initiated because the product failed an iron assay analysis during 18-month stability testing, indicating it was subpotent. This means the medication contained less active iron than required by specifications.
Healthcare providers and patients should discontinue use of the affected product. The FDA classifies this as a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE)
- Brand
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
- Manufacturer
- West-Ward Pharmaceuticals Corp.
- Hazard
- Affected units
- 5,142
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 (2)
- Lot #: 152032.1
- Exp. Date. 2/2017
Distribution
Distributed nationwide across the United States.
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