Usha Sharma – Mumbai
Sun Pharmaceutical Industries has announced a nationwide recall of nimodipine capsules 30 mg due to crystallisation of the fill material. The product is being manufactured by Maryland, US based Pharmaceutics International, Inc for Sun Pharmaceutical Industries and marketed in the US by Caraco Pharmaceutical Laboratories. The US Food and Drug Administration (US FDA) has been intimated of the recall as well.
In a statement to Express Pharma, a Sun Pharma spokesperson commented, “The required internal investigation on the matter is being conducted to get to the root cause and necessary corrections will be implemented.”
It may be recalled that two years ago, in September 2010, Sun Pharma had initiated a recall for the same product manufactured by the same company. At the time, the letter to the US FDA had stated CGMP deviations and leaking capsules as the reason for the voluntary recall.
When asked about the impact of the current recall, he commented that revenue loss would be negligible.
The company has already commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot as identified by a customer complaint. No adverse events have been reported at this point of time.
Nimodipine capsules, 30 mg, are used to decrease problems due to subarachnoid haemorrhage (bleeding in the brain). Nimodipine capsules 30 mg are clear yellow solution filled in oblong opaque light yellow softgel capsules, imprinted ‘135’ in black ink. The affected product was distributed across the US between January 19and April 24, 2012.
The crystallisation of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability. Although clinical health implications are unknown, use of the product when the nimodipine has crystallised in the capsule may be of great clinical significance. The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency.
As a precautionary measure, Sun Pharma has recalled the following lot numbers at the consumer level to minimise any potential risk to patients. They are:Lot number: 3305.039A, NDC number: 57664-135-65 (Unit dose blisters of 100 (25×4)) and Lot number: 3305.039B, NDC number: 57664-135-64 (Unit dose blisters of 30 (5×6)). The company has advised patients and healthcare providers using nimodipine capsules, 30 mg, with the above lot numbers to discontinue use of the product.