Domestic pharma firms continue to recall drugs

The voluntary drug recalls by the domestic drug manufacturers in the US market continues, according to the US Food and Drug Administrations (FDA) enforcement report.

Last week, FDA in its enforcement report found Aurobindo Pharmaceuticals, Macleods Pharmaceuticals, Heritage Pharmaceuticals, Hetero Laboratories and Lupin have recalled drugs due to various reasons.

Lupin's US arm Lupin Pharmaceuticals Inc has initiated a Class III voluntary recall of 3,200 bottles of testosterone topical solution, 30 mg/1.5 ml in 110 ml bottles on account of the defective container as repetitive complaints were received indicating pump was not working. The recalled products were distributed to seven major wholesale/ drug chain distributors and one supermarket chain that may have further distribute the product throughout the United States.

On the other hand, Hetero Labs, Aurobindo Pharma along with its group company Aurolife Pharma and Macleods Pharma have initiated a recall of hypertension drugs Valsartan, Valsartan and Amlodipine combination and Losartan tablets from the US market after FDA analysis found traces of potential human carcinogen in the active pharmaceutical ingredients (API) of these drugs.

A total of 11,05,085 bottles of Losartan Potassium tablets, manufactured by Hetero Labs Limited, are having an ongoing nationwide Class II recall due to deviation in current good manufacturing practices, as trace amounts of cancer-causing impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the API.

A class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. On the other hand, a class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Aurolife Pharma LLC, a step-down subsidiary of Aurobindo Pharma, has initiated a Class II voluntary recall of a total of 1,45,237 bottles of Valsartan tablets after a trace amount of unexpected impurity N-nitrosodiethylamine (NDEA) was detected in finished products.

Macleods Pharma, USA, has also initiated a similar voluntary recall of 9695 bottles of Losartan Potassium and hydrochlorothiazide tablets after they were detected of NDEA traces. Another domestic pharma company, Heritage Pharmaceuticals, has initiated Class II voluntary recall of 11,888 units of prescription-only Etomidate injection, USP 20 mg/10 ml (2 mg/ml) 10 ml single-dose vial. The injection is a short-acting intravenous anaesthetic agent used for the induction of general anaesthesia.