Class II · Moderate risk
Lithium Carb 150mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lithium Carbonate Extended-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
Affected NDC
0378-1300-01
Compare with the code on your package — it is the most precise check available.
Drug: Lithium
- Recalling firm
- Cardinal Healthcare
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0189-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
Mineral Mix Schrader
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Class II · Moderate risk
Lithium Carbonate ER
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD39588_10, EXP: 5/13/2014.
Class II · Moderate risk
Lithium Carbonate ER
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6
Class II · Moderate risk
Lithium Carbonate ER
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014.
Other recalls by Cardinal Healthcare
All 2022 recalls
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Triamterene and Hydrochlorothiazide Capsules
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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