Preferred Pharmaceuticals Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for recall — FDA D-1364-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Overview of recall records associated with Preferred Pharmaceuticals, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 33.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
This page summarizes recall records in which the official source identifies Preferred Pharmaceuticals, 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.