Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON…
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
Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little…
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy &…
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays…
Reason Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing…
Class II · Moderate risk Terminated
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only…
Reason Discoloration: presence of atypical yellow discoloration of the solution .
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b)…
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b)…
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b)…
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class I · High risk Terminated
PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix…
Reason Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10…
Class III · Low risk Ongoing
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label…
Class II · Moderate risk Terminated
Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC…
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT…
Reason Cross contamination with other products: metronidazole
Class III · Low risk Terminated
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911)…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the…
Class I · High risk Terminated
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV…
Reason Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code…
Reason PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…
Reason Presence of Particulate Matter: identified as cardboard.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…
Reason Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Class III · Low risk Terminated
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles…
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx…
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk Terminated
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only…
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ…
Reason Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class I · High risk Terminated
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare…
Reason Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class III · Low risk Terminated
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC…
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
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