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Atorvastatin Recall 2025: FDA recalls more than 140,000 bottles of cholesterol drug due to failure to dissolve.
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Atorvastatin Recall 2025: FDA recalls more than 140,000 bottles of cholesterol drug due to failure to dissolve.

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1 Atorvastatin Calcium Tablets USP, 10 mg, Rx only a) Bottle of 90 (NDC 67877-511-90), b). Bottle of 500 (NDC 67877-511-05), c). Bottle of 1000 (NDC 67877-511-10) Manufacturer: Alkem Laboratories, Ltd. India, Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. D-0017-2026 Class II Lot Number: 25141249, Exp. Lot #: 24144938, Expires February 2027. Lot #: 24144868, Expires November 2026. Lot #: 24144867, Expires November 2026. Lot #: 24144458, Expires November 2026. Lot #: 24143994, Expires September 2026. Lot #: 24142987, Expires September 2026. Lot #: 24143316, Expires July 2026. July 2026 141,984 bottles Failed dissolution specifications 2 Atorvastatin Calcium Tablets USP, 40 mg, Rx only, a). 90 (NDC 67877-513-90), b). 500 counts (NDC 67877-513-05), c). 1000 sheets (NDC 67877-513-10), Manufacturer: Alkem Laboratories, Ltd. India, Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. D-0018-2026 Class II Lot Number: 25140933, Expired. Lot #: 25140477, Expires February 2027. Lot #: 24144254, Expires December 2026. Lot #: 24144163, Expires October 2026. Lot #: 24143995, Expires September 2026. September 2026 Not applicable Failed dissolution specifications 3 Atorvastatin Calcium Tablets USP, 20 mg, Rx only, a). 90 (NDC 67877-512-90), b). 500 counts (NDC 67877-512-05), c). 1000 sheets (NDC 67877-512-10), Manufacturer: Alkem Laboratories, Ltd. India, Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. D-0019-2026 Class II Lot Number: 25140150, Exp. Lot #: 25140173, Expires December 2026. Lot #: 25140172, Expires December 2026. Lot #: 24144720, Expires December 2026. Lot #: 24144798, Expires November 2026. Lot #: 24144692, Expires November 2026. Lot #: 24143755, Expires October 2026. Lot #: 24143913, Expires August 2026. August 2026 Lot #: See more… Not applicable Failed dissolution specifications 4 Atorvastatin Calcium Tablets USP, 80 mg, Rx only, a). 90 (NDC 67877-514-90), b). 500 sheets (NDC 67877-514-05), Manufacturer: Alkem Laboratories, Ltd. India, Distributor: Ascend Laboratories, LLC, Parsippany, NJ 07054 D-0020-2026 Class II Lot Number: 25140249, Exp. Lot #: 25140247, Expires December 2026. Lot #: 24144999, Expires December 2026. Lot #: 24144942, Expires November 2026. Lot #: 24144845, Expires November 2026. Lot #: 24144713, Expires November 2026. Lot #: 24144652, Expires November 2026. Lot #: 24143898, Expires October 2026. Lot #: 24143412, Expires August 2026. Lot #: 24143582, Expires August 2026. August 2026 Not applicable Failed dissolution specifications



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