Sulfites Recalls in the United States

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

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Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

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JCB Labs LLC recalls Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection,

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

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Hospira Inc. recalls Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solut

Lack of Assurance of Sterility; potential leakage from administrative port.

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Baxter Healthcare Corp recalls ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL V

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

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Baxter Healthcare Corp. recalls Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Elect

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

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Baxter Healthcare Corp recalls Clinimix E 5/20 sulfite-free (5% amino-acid with electrolyte

Lack of Assurance of Sterility; increased complaints received for leaks

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Fresenius Kabi USA, LLC recalls KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

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Hospira Inc. recalls Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

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Pharmedium Services, LLC recalls morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodiu

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

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Pharmedium Services, LLC recalls morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Pr

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

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Pharmedium Services, LLC recalls morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodiu

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

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Baxter Healthcare Corporation recalls 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bu

Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

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Key Pharmacy and Compounding Center recalls PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, R

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

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