Alkem Laboratories Limited
Amaliya Daman, India · makes it
No problems found Last FDA inspection Aug 30, 2019. 6 inspections on record.
NDC 67877-511
Atorvastatin Calcium 10 mg tablet, film coated
On the label: Ascend Laboratories, LLC.
Where it's made
Recalls
- Sep 19, 2025 · Class II · Ongoing
Failed Dissolution Specifications
Lots: Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026 - Sep 19, 2025 · Class II · Ongoing
Failed Dissolution Specifications
Lots: Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026 - Sep 19, 2025 · Class II · Ongoing
Failed Dissolution Specifications
Lots: Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: … - Sep 19, 2025 · Class II · Ongoing
Failed Dissolution Specifications
Lots: Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp.…
Product details
- Generic drug
- Atorvastatin: see every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA209288
- On the market since
- Dec 23, 2018
- Package NDCs
67877-511-0567877-511-1067877-511-3367877-511-3867877-511-5567877-511-90- Official label
- DailyMed (National Library of Medicine), updated Apr 29, 2025
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