Lincare, Inc.
Complete recall history across all FDA and CPSC categories — 54 total recalls
Lincare, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (54)
FDA drug safety enforcement actions by Lincare, Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 28, 2015 | Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: U... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by:... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Co... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded b... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: U... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only.... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, R... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: Unit... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syrin... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intra... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intr... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intr... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only. Compounded by... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded b... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Cl... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Fluorouracil 3200mg / D5W 264mL, Qty: 1 264 mL Bag, Rx Only. Compounded by: ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Onl... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Tra... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx O... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Cl... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Onl... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only. Compounded by: U... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only. Compo... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Trava... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags,... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: U... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. ... | Lack of Assurance of Sterility: Sterility of product is not assure | Class II |
| May 28, 2015 | TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL sy... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounde... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intra... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Onl... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only... | Lack of Assurance of Sterility: Sterility of product is not assured | Class II |
| May 28, 2015 | Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: ... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travaso... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
| May 28, 2015 | Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag... | Lack of Assurance of Sterility: Sterility of product is not assured. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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