685 FDA recalls mention Pine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pine.
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradations Specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Stability Data Does Not Support Expiry Date.
Reason Stability Data Does Not Support Expiry Date.
Reason Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Reason Defective container: cracked/broken cartridges
Reason Defective container: cracked/broken cartridges
Reason Presence of Particulate Matter
Reason Failed Dissolution Specifications.
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
Reason Lack of Assurance of Sterility.
Reason Failed Dissolution Specifications: low dissolution results
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Reason Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Reason Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
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