
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an...
Page 5 of 40 · 1,986 total recalls

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an...

Potential physical contamination: dark spot was noticed on the bottom of container.


Incorrect product formulation: bag did not contain copper and famotidine per label.



CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection




CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection

CGMP Deviations; deficiencies observed during FDA inspection




Improperly eviscerated which may result in Clostridium botulinum contamination

Undeclared sodium tripolyphosphate (STTP)

Undeclared sodium tripolyphosphate (STTP)

Undeclared sodium tripolyphosphate (STTP)

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not...

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not...

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not...

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not...

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not...

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not...

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of...

Microbial Contamination of Non-Sterile Products

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.


Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.


Product contaminated with Listeria monocytogenes.

Product contaminated with Listeria monocytogenes.

Labeling: Incorrect or Missing Lot and/or Exp Date

Failed Impurities/Degradation Specifications
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