Overview of recall records associated with RemedyRepack Inc., including dates, categories and classifications where available.
Classification mix: Class II: 28, Class III: 2, Class I: 1.
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
cGMP Deviations
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product…
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per…
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium…
This page summarizes recall records in which the official source identifies RemedyRepack Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
