Hospira Recalls Lactated Ringer's Injection Due to CGMP Deviations
Hospira is recalling 1,296 units of Lactated Ringer's Injection, USP, 1000 mL, because the product was shipped without approval for release.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Hospira, Inc. is recalling 1,296 units of Lactated Ringer's Injection, USP, 1000 mL (NDC 0409-7953-09). The affected product is identified by Lot 16-836-FW with an expiration date of 04/14.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the shipment of product that was not approved for release. The distribution pattern is listed as NC.
This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact their supplier or Hospira for further instructions.
The recalled product
- Product
- Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
- Manufacturer
- Hospira, Inc.
- Category
- Drug — IV Fluids
- Affected units
- 1,296
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 16-836-FW
- Exp 04/14
Distribution
Distributed in 1 state:
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