Class II · Moderate risk
Liothyronine Sodium USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Thyroid Medication Recalls
Recalls of levothyroxine and other thyroid hormone replacement drugs, often over sub-potency.
235 recalls in this category, newest first.
Class II · Moderate risk
Levothyroxine Sodium USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Liothyronine SR
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
LEVOXYL (levothyroxine sodium tablets, USP)
Superpotent
Class II · Moderate risk
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules
Superpotent Drug and Subpotent Drug; potency failures obtained
Class II · Moderate risk
All thyroid Products
Lack of Processing Controls
Class II · Moderate risk
All T4-levothyroxine Products
Lack of Processing Controls
Class II · Moderate risk
All methimazole Products
Lack of Processing Controls
Class II · Moderate risk
Thyroid Porcine active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Methimazole active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Liothyronine Sodium
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Levothyroxine Sodium
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Liothyronine Sodium Tablets
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Class II · Moderate risk
Liothyronine Sodium
Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 25 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00378181701, Pedigree: W003151, EXP: 6/13/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003000, EXP: 6/11/2014.
Class II · Moderate risk
Liothyronine Sodium
Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 5 mcg may have potentially been mislabeled as one of the following drugs: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 00574022201, Pedigree: W003152, EXP: 4/30/2014.
Class II · Moderate risk
Levothyroxine Sodium
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD60272_70, EXP: 5/22/2014.
Class II · Moderate risk
Levothyroxine Sodium
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD46265_34, EXP: 5/15/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003008, EXP: 6/11/2014.
Class II · Moderate risk
Levothyroxine Sodium
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD60272_19, EXP: 5/22/2014.
Class II · Moderate risk
Levothyroxine Sodium
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: W003007, EXP: 6/12/2014.
Class II · Moderate risk
Levothyroxine Sodium
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg) may have potentially been mislabeled as one of the following drugs: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD30180_1, EXP: 5/8/2014; carBAMazepine ER, Capsule, 200 mg, NDC 66993040832, Pedigree: AD32764_14, EXP: 5/14/2014; CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 00378022201, Pedigree:
Class II · Moderate risk
Thyroid
Labeling: Label Mixup: THYROID, Tablet, 60 mg may have potentially been mislabeled as the following drug: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: W002847, EXP: 6/7/2014.
Class II · Moderate risk
Thyroid
Labeling: Label Mixup: THYROID, Tablet, 30 mg may have potentially been mislabeled as one of the following drugs: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, NDC 11523726503, Pedigree: AD70655_20, EXP: 5/29/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 37205098769, Pedigree: AD73623_7, EXP: 5/30/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W002697, EXP: 6/5/2014.
Class II · Moderate risk
Levothyroxine Sodium
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 1 mg, NDC 16714058701, Pedigree: W003150, EXP: 6/13/2014.
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