Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Drug: Nortriptyline
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.
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
CGMP deviations.
Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 75 mg may have potentially been mislabeled as one of the following drugs: guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD21790_58, EXP: 5/1/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141509, Pedigree: W003693, EXP: 4/30/2014.
Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 50 mg may have potentially been mislabeled as one of the following drugs: ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: AD21811_10, EXP: 5/2/2014; LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 42794001802, Pedigree: AD46414_38, EXP: 5/16/2014.
Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 10 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD70585_1, EXP: 5/29/2014.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
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