Yes — there is an active recall. 82 ongoing FDA recalls mention Pine (685 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Reason Presence of Foreign Substance; metal shard found in tablet
Reason Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe…
Reason Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe…
Reason Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May…
Reason Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Reason Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Reason Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Subpotent Drug: Product may not have the active ingredient present in the bag.
Reason CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Reason CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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