Safety Alerts and Recalls, Uncategorized
Arbor announced a Class II drug recall of three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution due to possible degradation of the effervescent tablets.
Safety Alerts and Recalls, Uncategorized
Medline Industries announced the initiation of a voluntary recall of uncoated compressed acetaminophen 500mg tablets at the consumer level due to incorrect labeling.
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Rarely, acetaminophen use may cause three serious skin reactions, two of which may be fatal.
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Advance Pharmaceuticals is conducting a voluntary recall of the over-the-counter drug, Rugby label Enteric-Coated Aspirin Tablets, 81mg, Lot 13A026 after receiving a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81mg actually containing Acetaminophen 500mg tablets.
Uncategorized
Watson Laboratories has issued a nationwide voluntary recall of two lots of Hydrocodone Bitartrate and Acetaminophen 10 mg/500 mg Tablets due to potentially oversized tablets.
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Qualitest has issued a nationwide voluntary recall of one lot of Hydrocodone Bitartrate and Acetaminophen 10mg/500mg Tablets due to potentially oversized tablets.
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The FDA has notified healthcare professionals and patients that a 160mg/5mL additional concentration of liquid acetaminophen for infants is now available.
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McNeil Consumer Healthcare has notified healthcare providers of an industry-wide transition to a single concentration of 160mg/5mL for all over-the-counter pediatric single-ingredient liquid acetaminophen products.
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An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B.
Uncategorized
The FDA is asking manufacturers of acetaminophen (APAP)-containing prescription combination products to limit the amount of APAP to a maximum of 325mg per tablet or capsule because of continued reports of liver injury.
