Homeopathic Product Under Drug Recall for Undeclared Penicillin
Terra-Medica, Inc has issued a voluntary drug recall for homeopathic remedies in liquid, tablet, capsule, ointment, and suppository forms after learning that their products were contaminated with penicillin, making them an undeclared drug according to FDA regulations.
The remedies under the drug recall include 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX. The remedies will have the label “Distributed by SANUM USA Corp,” and they were distributed nationwide through heath care practitioners, or through some retail websites.
Reportedly, the FDA determined that these products may contain penicillin or derivatives of penicillin, which could be produced during the products’ fermentation process.
Some potential users may be allergic to penicillin, prompting the drug recall. Allergic reactions can range from mild rashes to life-threatening anaphylactic reactions.
New Research Shows Unapproved Ingredients in Dietary Supplements Cause Half of Dangerous Drug Recall
US researchers have found that dietary supplements, which often contain unapproved or unlisted ingredients, make up just over half of all dangerous drug recalls in the United States.
Most of the dangerous drug recalls were issued for supplements that claimed to boost sexual performance, build muscle, or aid weight loss. “Supplements” are allowed to contain vitamins, minerals, and herbs, but they are not allowed to contain pharmaceuticals.
The study called for much more stringent guidelines to regulate dietary supplements. Currently, the market has very little FDA oversight. Federal law does not require that supplements – which are supposedly herbal rather than pharmaceutical – go through the FDA for approval before they can be packaged and sold.
However, because of the lack of oversight, supplements containing pharmaceutical compounds have entered the market.
Harel and colleagues used data collected by the FDA about Class I recalls from between January 1, 2004, to December 19, 2012. Of the 465 recalled drugs, 237 were dietary supplements. Nine out of ten of the supplement recalls occurred after 2008. All of the dangerous drug recalls were issued due to unapproved pharmaceutical ingredients. An additional 110 supplements were known to contain unapproved pharmaceuticals, but were not recalled.
About 24% of the recalled supplements were manufactured outside the US. The study noted this is a concern, as other countries do not adhere to the same manufacturing practices. In the US, supplement manufacturers are expected to adhere to current good manufacturing practices (CGMP) as defined by federal regulations. However, the study also noted that at least half the supplements manufactured in the US violated CGMP.
The Strom Law Firm Can Help with Dangerous Drug Recall Cases
The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using dangerous drugs, tainted dietary supplements, or medical devices that did not receive a proper drug recall, dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800