The Bulgarian Drug Agency, a Health Ministry-run body, said on October 14 2008 that it was blocking the delivery and sale of the AstraZeneca heart/cardiac medication Betaloc Zoc (tablet 50 mg x 28) to and in pharmacies around the country because the packaging of the medication did not meet Bulgarian Drug Agency (BDA) standards.

According to a statement published on the BDA website, writing on the packaging was illegible and it did not meet the requirements “that apply to medicines of the second degree of risk as set forth in point 1 of the classification of degrees of health risks due to medications in discrepancy with the requirements for quality in accordance with regulation 9 of the Health Ministry. The outside packaging of the medicinal product does not meet the requirements of the Law on Medicinal Products in Human Medicine (incorrect and illegible labelling, with tablets missing in the blister pack, incorrectly trimmed blister pack with writing on the inside of the aluminium foil).”

BDA has given AstraZeneca 24 hours to stop distribution and sale of the product.

In a press statement issued on the morning of October 14, AstraZeneca said that packaging of the metoprolol succinate (a beta-blocker) medication was in full accordance with BDA standards.

“AstraZeneca will work with the regulatory bodies to clarify the situation. At the same time, the product will remain available for purchase in pharmacies in prescription bottles,” the company said.