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.
Is Verapamil recalled?
17 FDA recalls mention Verapamil. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Verapamil.
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 III · Low risk Ongoing
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by…
Reason Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by…
Reason Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by…
Reason Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class II · Moderate risk Terminated
Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex…
Reason Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Class II · Moderate risk Terminated
Verapamil HCl 15% Topical Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
VERAPAMIL HCL, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591040401.
Reason Labeling: Label Mixup: VERAPAMIL HCL, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM…
Class II · Moderate risk Terminated
VERAPAMIL HCL ER, Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378644001.
Reason Labeling: Label Mixup: VERAPAMIL HCL ER, Capsule, 240 mg may have potentially been mislabeled as the following drug: FEBUXOSTAT, Tablet, 40 mg, NDC…
Class II · Moderate risk Terminated
VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462026001
Reason Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLUOPERAZINE HCL, Tablet, 1 mg, NDC 00781103001…
Class II · Moderate risk Terminated
Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Class II · Moderate risk Terminated
VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAMIL HCL, SDV*** (5X2ML VIAL) 2.5MG/ML…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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