Class II · Moderate risk Terminated
Entertainer's Secret Throat Relief
Reason Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Alprazolam tablets
Reason Subpotent Drug
Class II · Moderate risk Terminated
J-TAN D PD Drops
Reason Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Class II · Moderate risk Terminated
Gabapentin Capsules
Reason Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk Terminated
Gabapentin Capsules
Reason Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk Terminated
Gabapentin Capsules
Reason Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk Terminated
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Reason Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class II · Moderate risk Terminated
Glutathione 200 mg/mL Injectable
Reason Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Class II · Moderate risk Terminated
Fentanyl Citrate Injection
Reason Lack of Assurance of Sterility; improperly crimped fliptop vials
Class II · Moderate risk Terminated
Tikosyn
Reason Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Class II · Moderate risk Terminated
Benzonatate Capsules
Reason Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Class II · Moderate risk Terminated
Clinimix E 4.25/10 sulfite-free
Reason Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Class II · Moderate risk Terminated
HydrALAZINE Hydrochloride Tablets
Reason Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Class II · Moderate risk Terminated
Ginseng Kianpi Pil
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Class II · Moderate risk Terminated
Mercaptopurine Tablets
Reason Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Class II · Moderate risk Terminated
Zonisamide active pharmaceutical ingredient packaged in varying…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Zolmitriptan active pharmaceutical ingredient packaged in varying…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Zoledronic Acid active pharmaceutical ingredient packaged in…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Zinc Pyrithione active pharmaceutical ingredient packaged in…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Zidovudine active pharmaceutical ingredient packaged in varying…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Voriconazole active pharmaceutical ingredient packaged in varying…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Vincristine Sulfate active pharmaceutical ingredient packaged in…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Vidarbine Monophosphate active pharmaceutical ingredient packaged…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Venlafaxine HCl active pharmaceutical ingredient packaged in…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Vecuronium Bromide active pharmaceutical ingredient packaged in…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.