Class III · Low risk Terminated
Oxybutynin Chloride
Reason Failed Dissolution Specifications
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
Cefuroxime 10 mg/mL in Sodium Chloride
Reason Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class II · Moderate risk Terminated
Indian Herb Paste
Reason Unapproved new drug
Class III · Low risk Terminated
Oxytocin 30 Units added to NS 500 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated
Oxytocin 20 Units added to NS 1000 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated
Oxytocin 10 Units added to NS 1000 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class II · Moderate risk Terminated
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Reason Labeling: Incorrect expiration date.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
Dymista
Reason Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II · Moderate risk Terminated
NORepinephrine 16 mg added to 0.9% Sodium Chloride
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
HEPERAIN 50 mg/50 mL
Reason Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Class III · Low risk Terminated
COSOPT Ophthalmic Solution
Reason Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class II · Moderate risk Terminated
Myer's Cocktail
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Oxybutynin Chloride Tablets
Reason Labeling: Wrong bar code
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class III · Low risk Terminated
Norepinephrine 8 mg
Reason Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class II · Moderate risk Terminated
Germ Bloc Health Hand Sanitizer Foam
Reason Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class I · High risk Terminated
Sodium Chloride Injection
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Class I · High risk Terminated
Sodium Chloride Injection
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Class II · Moderate risk Terminated
Equi-Soft Foam
Reason Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Class I · High risk Terminated
Levetiracetam in 0.54 % Sodium Chloride Injection 1
Reason Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Class II · Moderate risk Terminated
Alcohol Free Foaming Hand Sanitizer
Reason CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk Terminated
deb stoko
Reason CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk Terminated
Catapres .2
Reason Failed Dissolution Specifications: OOS resultsduring routine stability testing
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