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Product Batch Recall

Reporting product or batch defects that could result in a recall:

Any product or batch defect relating to a product sold in the UK should be reported to the VMD.

Details should be sent to Lee Grist l.grist@vmd.defra.gsi.gov.uk (01932 338372) using the Product Defect Report form (.doc 134kb).

Where a defect is likely to result in a recall of a batch or product please contact the VMD for advice and where appropriate give details of the level of recall, e.g. wholesaler level, veterinary practice level.

What defects could necessitate a product or batch recall?:

  • Incorrect labelling, e.g. the strength of the product, the name of the active ingredient.
  • Misinformation or lack of information in the product literature.
  • Incorrect manufacture, e.g. the strength of the product ingredients, the product container.
  • Contamination, e.g. chemical, microbial, physical.
  • Stability, e.g. expiry.
  • Counterfeit or deliberately tampered-with product.

Legal basis:

Each holder of an authorisation referred to in Article 44 of Directive 2001/82/EC (for veterinary products) is required by Article 13 of Directive 91/412/EEC (for veterinary products) to implement an effective procedure for the recall of defective products. The authorisation holder is required to notify the relevant Competent Authority of any defect that could result in a recall and indicate, as far as possible, the countries of destination of the defective product.

Batch Recalls:

Date Product Batch No. Problem
13 June 2014 Clamoxyl Long Acting 150 mg/ml Suspension for Injection 36948103, 36948201 The product was difficult to withdraw from bottles and led to blockages of needles when expelling the product from the syringe.
5 June 2014 Porcilis Ery+Parvo A157A, A157B, A157C Out of specification results were discovered for the parvo component during the ongoing stability tests.
5 June 2014 Vetzyme JDS 1% w/w Insecticidal Dog Shampoo 3L13, 3L49, 4B71, 4C51 The shampoo was no longer homogeneous due to precipitation of both the primary surfactant and the active substance permethrin.
3 June 2014 Rispoval Pasteurella T32041, T32669, T33784, T30415, T33066, T33067 15 month stability sample tests did not pass particle size specifications and had an abnormal appearance.
30 May 2014 Gleptosil 200 mg per ml Solution for Injection 0241H Potential lack of expected efficacy issue due to a filtration issue during manufacture.
27 March 2014 Voren Suspension for Injection, 1 mg/ml F20557-29, F20556-29, F20552-28, F20528-25, E20548-23 Presence of precipitations or adhesions in product vials that were not re-suspendable within 1min of shaking (as defined in the product specification).
6 February 2014 Panacur Small Animal 10% Oral Suspension E301A01 100ml bottle manufactured without a foil seal as part of the container closure.

For information on human medicines (MHRA Latest Drug Alerts):

More information can be found on the MHRA Safety Information page which includes current and historic alerts:

  • Drug alerts on defective medicines.
  • Medical device alerts and their predecessors.
  • Safety warnings and messages about medicines, including letters sent to health professionals.
Last Updated: 26 August 2014

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