Class II · Moderate risk Ongoing
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India…
Reason Failed Impurities/Degradation Specifications
Is Hydralazine recalled?
18 FDA recalls mention Hydralazine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydralazine.
Class II · Moderate risk Ongoing
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick…
Reason Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class II · Moderate risk Terminated
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for…
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…
Class III · Low risk Ongoing
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…
Class III · Low risk Terminated
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health…
Reason Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class II · Moderate risk Ongoing
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR…
Reason Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II · Moderate risk Terminated
HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP…
Reason Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the…
Class III · Low risk Terminated
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA…
Reason Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Class II · Moderate risk Terminated
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring…
Reason Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small…
Class II · Moderate risk Terminated
Hydralazine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech…
Reason Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class II · Moderate risk Terminated
Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o…
Reason Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class II · Moderate risk Terminated
hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801
Reason Labeling: Label Mixup; hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 12.5 mg, NDC 00143117101, Pedigree…
Class II · Moderate risk Terminated
HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032701
Reason Labeling: Label Mixup; HYDRALAZINE HCL Tablet, 25 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501…
Class II · Moderate risk Terminated
hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401
Reason Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree…
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