Recall category
Finished prescription and over-the-counter drugs that patients can identify from packaging or pharmacy records.
Crystallization; identified as Buprenorphine free base
Missing from associated official evidence: action.
Failed Dissolution Specifications
Missing from associated official evidence: action.
Defective container:may contain bottles with incomplete seals
Missing from associated official evidence: action.
Labeling: Incorrect or Missing Lot and/or Exp Date
Missing from associated official evidence: action.
CGMP Deviations; deficiencies observed during FDA inspection
Missing from associated official evidence: action.
Subpotent Drug
Missing from associated official evidence: action.
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Missing from associated official evidence: action.
Microbial Contamination of Non-Sterile Products
Missing from associated official evidence: action.
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Missing from associated official evidence: action.
Presence of Particulate matter: Particulate matter identified as glass.
Missing from associated official evidence: action.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Missing from associated official evidence: action.
Failed Impurities/Degradations Specifications
Missing from associated official evidence: action.
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Missing from associated official evidence: action.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Missing from associated official evidence: action.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Missing from associated official evidence: action.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Missing from associated official evidence: action.
Microbial contamination of sterile products
Missing from associated official evidence: action.
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Missing from associated official evidence: action.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Missing from associated official evidence: action.
Presence of foreign substance: small metallic particles in chewable tablets.
Missing from associated official evidence: action.
Lack of Assurance of Sterility
Missing from associated official evidence: action.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Missing from associated official evidence: action.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Missing from associated official evidence: action.
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Missing from associated official evidence: action.
