Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 8, 2015
TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc. recalled TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, W… - a moderate-severity action.
TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, W… was recalled by Lincare, Inc. in July 8, 2015. Reason: Lack of Assurance of Sterility: Sterility of product is not assured.. Check the official notice for the remedy. Verify recall #D-1161-2015 with the FDA Drug before acting.
The recall
Lincare, Inc. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: Sterility of product is not assured..
- Moderate
- severity level
- Class II
- classification
- July 8, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1161-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1161-2015) was formally reported on July 8, 2015, with the manufacturer initiating the action on May 28, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Lincare, Inc. is listed as the recalling firm, operating out of Little Rock, AR. Federal records list the affected scope as 5 Bags.
The documented reason for this recall is: Lack of Assurance of Sterility: Sterility of product is not assured. Distribution data in the federal record shows the product reached: United States including: Arkansas. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Dietary Supplements recalls over time
Where this recall sits in its category - 2,002 dietary supplements recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5 Bags
Related Recalls
6
0 from same agency
Product description
TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Reason for recall
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1161-2015 |
| Date reported | July 8, 2015 |
| Date initiated | May 28, 2015 |
| Recalling firm | Lincare, Inc. |
| Firm location | Little Rock, AR |
| Affected scope | 5 Bags |
| Distribution | United States including: Arkansas |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1161-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.. Recalled by Lincare, Inc.. Units affected: 5 Bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Sterility of product is not assured.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 8, 2015. Severity: Moderate. Recall number: D-1161-2015.
Where was the recalled product distributed? ▼
Distribution: United States including: Arkansas.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1161-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 8, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.