Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
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
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ranitidine Hydrochloride
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
ranitidine hydrochloride
Reason CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class III · Low risk Terminated
Proparacaine Hydrochloride Ophthalmic Solution
Reason Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Class III · Low risk Terminated
Memantine Hydrochloride Extended-release Capsules
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk Terminated
Memantine Hydrochloride Extended-release Capsules
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class II · Moderate risk Terminated
Raloxifene Hydrochloride Tablets
Reason Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Class II · Moderate risk Terminated
Amantadine Hydrochloride Tablets
Reason Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Class II · Moderate risk Terminated
Vancomycin Hydrochloride for Injection
Reason Discoloration: Product complaints of discoloration after reconstitution of vials.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation USP 5000 mL bags
Reason Lack of Assurance of Sterility: Product has the potential to leak.
Class II · Moderate risk Terminated
fentaNYL 550 mcg/55 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1000 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 800 mcg/200 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1250 mcg/250 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 400 mcg/200 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 2000 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 400 mcg/200 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1000 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 400 mcg/200 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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