Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Reason Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Reason Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Reason Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices…
Reason Labeling: Missing Label
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…
Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…
Reason Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
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