Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services…
Reason cGMP violations
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
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services…
Reason cGMP violations
Class II · Moderate risk Terminated
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services…
Reason CGMP violations
Class II · Moderate risk Ongoing
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29…
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk Terminated
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Reason Temperature abuse: Products exposed to improper temperature above drug label specifications.
Class I · High risk Ongoing
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose…
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class I · High risk Ongoing
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Reason Presence of Particulate Matter
Class III · Low risk Terminated
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g…
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
Class III · Low risk Ongoing
Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by…
Reason Cross contamination with other products.
Class III · Low risk Ongoing
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC…
Reason Cross contamination with other products.
Class II · Moderate risk Terminated
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ…
Reason CGMP Deviations: Out of specification for dissolution
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only…
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and…
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila…
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class II · Moderate risk Terminated
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen…
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark…
Reason CGMP Deviations
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark…
Reason Failed Dissolution Specifications
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock…
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Ongoing
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For…
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Terminated
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use…
Reason Lack of Assurance of Sterility.
Class III · Low risk Completed
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma…
Reason Labeling: Wrong Barcode
Class I · High risk Completed
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36…
Reason Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
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