Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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 Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
oxyTOCIN 30 Units/500 mL
Reason Subpotent drug - Product did not contain drug.
Class II · Moderate risk Completed
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Class III · Low risk Terminated
Memantine Hydrochloride Extended-Release Capsules
Reason Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class III · Low risk Terminated
R.E.C.K.
Reason Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Class II · Moderate risk Terminated
Phentermine Hydrochloride Capsules
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL…
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
succinylcholine Chloride
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
fentaNYL Citrate 10 mcg per mL
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
HYDROmorphone in 0.9% Sodium Chloride HCl
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
nICARdipine HCl
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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