Class II · Moderate risk Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755…
Reason Lack of Assurance of Sterility
Is Chloride recalled?
Yes — there is an active recall. 326 ongoing FDA recalls mention Chloride (1,994 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories…
Reason Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class I · High risk Ongoing
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class III · Low risk Terminated
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC…
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd…
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd…
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi…
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class I · High risk Ongoing
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous…
Reason Presence of Particulate Matter: Silicone
Class I · High risk Ongoing
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For…
Reason Presence of Particulate Matter: Silicone
Class III · Low risk Terminated
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd…
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Terminated
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd…
Reason Labeling: Not Elsewhere Classified
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