Impurity Prompts Two Firms to Recall Tablets

The presence of an N-nitroso cinacalcet impurity above the acceptable daily intake limit has prompted Accord Healthcare Inc. and Dr Reddy’s Laboratories to recall dozens of lots of cinacalcet tablets. The recalls were published in the November 6, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The Accord Healthcare recall affects the following products, which were manufactured for Accord Healthcare, Durham, North Carolina, by Intas Pharmaceuticals Limited, Ahmedabad, India, and distributed throughout the United States and in Puerto Rico:

• cinacalcet tablets, 30 mg, packaged in 30-count bottles (NDC 16729-440-10), from lots M2118190 (Exp. 11/24), M2201091 (Exp. 11/24), M2206241 (Exp. 11/24), M2206451 (Exp. 4/25), M2208674 (Exp. 6/25), M2213850 (Exp. 8/25), M2215221 (Exp. 9/25), M2216236 (Exp. 11/25), M2217098 (Exp. 11/25), and M2300664 (Exp. 11/25);
• cinacalcet tablets, 30 mg, packaged in 90-count bottles (NDC 16729-440-15), from lots M2210808 (Exp. 6/25), M2212212 (Exp. 8/25), M2214435 (Exp. 9/25), M2217097 (Exp. 11/25), and M2301921 (Exp. 1/26);
• cinacalcet tablets, 60 mg, packaged in 30-count bottles (NDC 16729-441-10), from lots M2204481 (Exp. 2/25), M2212389 (Exp. 8/25), M2214271 (Exp. 9/25), M2215970 (Exp. 10/25), and M2216458 (Exp. 10/25);
• cinacalcet tablets, 60 mg, packaged in 90-count bottles (NDC 16729-441-15), from lots M2212869 (Exp. 8/25), M2216362 (Exp. 9/25), and M2215969 (Exp. 10/25);
• cinacalcet tablets, 90 mg, packaged in 30-count bottles (NDC 16729-442-10), from lot M2303264 (Exp. 1/26); and
• cinacalcet tablets, 90 mg, packaged in 90-count bottles (NDC 16729-442-15), from lot M2306979 (Exp. 4/26).

The Dr Reddy’s Laboratories recall affects the following products, which were made in India and distributed throughout the United States: 

• cinacalcet tablets, 30 mg, packaged in 30-count bottles (NDC 43598-367-30), from lots T2200120, T2200121, T2200119, T2200116, T2200118, T2200117 (Exp. 11/24); T2200695, T2200694, T2200696, T2200697 (Exp. 1/25); T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431 (Exp 3/25); T2202743, T2202742, T2202741 (Exp. 6/25); T2203081, T2203079, T2203080, T2203082, T2203083, T2203084 (Exp. 7/25); T2300770, T2300771, T2300769, T2300766, T2300767, T2300768 (Exp. 12/25); T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658, T2301659 (Exp. 2/26); T2304704, T2304703, T2304705, T2304706 (Exp. 8/26); and T2400468, T2400469, T2400473, T2400474 (Exp. 11/26);
• cinacalcet tablets, 60 mg, packaged in 30-count bottles (NDC 43598-368-30), from lots T2200698 (Exp. 1/25); T2201444 (Exp. 3/25); T2202827 (Exp. 6/25); T2300531 (Exp. 12/25); T2301696 (Exp. 2/26); T2304726 (Exp. 8/26); and T2400480 (Exp. 11/26); and
• cinacalcet tablets, 90 mg, packaged in 30-count bottles (NDC 43598-369-30), from lots T2201443 (Exp. 3/25); and T2300664 (Exp. 12/25).

Dr Reddy's Laboratories initiated its recalls on October 9, 2024, and Accord Healthcare on October 10, 2024. The FDA designated them Class II in late October. Per the classification, use of the product could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Cinacalcet is a prescription calcium reducer with indications for secondary hyperparathyroidism, parathyroid carcinoma, and primary hyperparathyroidism.