Mercury Pharmaceuticals Ltd is recalling remaining stock of the antipsychotic medication, paliperidone, due to Good Manufacturing Practice (GMP) deficiencies cited during a recent inspection at the finished product manufacturing site.
The affected medicines are Paliperidone Mercury Pharma 50mg, 75mg, 100mg and 150mg prolonged-release suspensions for injection in pre-filled syringes.
This recall is precautionary and relates to manufacturing standards rather than a confirmed problem with the medicine itself. Mercury Pharmaceuticals Ltd has not identified any adverse events related to this issue.
Healthcare professionals have been advised to stop suppling the recalled batches immediately, to quarantine all stock and return it to their supplier using their supplier’s approved process.
Mercury Pharmaceuticals Ltd has confirmed that due to the ongoing remedial actions at the finished product manufacturing site, there may be delays in the manufacture of future batches.
Where paliperidone Mercury Pharma prolonged-release injections are unavailable, clinicians should consider alterative licensed treatment options to ensure continuity of care.
These may include an alternative paliperidone palmitate product, another long-acting injectable antipsychotic, or, where clinically appropriate, an oral antipsychotic.
Patients have been advised to contact their prescriber to arrange treatment without interruption.
Affected lot batch numbers
Paliperidone Mercury Pharma 50 mg prolonged-release suspension for injection in pre-filled syringe:
- 4400353
- 4301747
- 4400797
- 4401269
- 4401271
Paliperidone Mercury Pharma 75 mg prolonged-release suspension for injection in pre-filled syringe:
- 4301534
- 4301945
- 4301883
- 4400979
- 4400711
- 4401437
- 4500150R
- 4500154R
- 4500171R
- 4500176
- 4500443R
- 4501272
Paliperidone Mercury Pharma 100 mg prolonged-release suspension for injection in pre-filled syringe:
- 4301518
- 4301550
- 4301970
- 4400390
- 4400737
- 4401361
- 4500100
- 4500280
- 4500675
- 4500750
- 4500825
- 4500894
- 4501516
Paliperidone Mercury Pharma 150 mg prolonged-release suspension for injection in pre-filled syringe:
- 4301538
- 4301930
- 4301817
- 4401337
- 4401338
- 4401277
- 4400150
- 4400169
- 4500200
- 4500197R
- 4500596
- 4500689
- 4500709R
- 4501340
- 4501371
Patients who experience any adverse reactions should seek medical attention and report them via the MHRA Yellow Card scheme.
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