All rights reserved. The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles. Get Synthroid Coupon Card by print, email or text and save up to 74% off Synthroid at the pharmacy. Get Synthroid Coupon Card by print, email or text and save up to 74% off Synthroid at the pharmacy.
Enter your email address to subscribe to this blog and receive notifications of new posts by email. Find Recalls from September 2020 on ConsumerAffairs. The shortage is a result of hurricanes Irma and Maria, which hit Puerto Rico nearly four months ago, and knocked out manufacturing facilities for many drugs and medical supplies, including levothyroxine. SYNTHROID® (levothyroxine sodium) tablets, for oral use is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. Interestingly, synthetic levothyroxine is held to even higher standards, as a drug designated to have a “narrow therapeutic index.” The specifications were updated from 90-110% to a “narrowed 95–105% potency acceptance range for L-T4 tablets in the 2006 update to the FDA Guidance” (Eisenberg and Distefano, 2009). Healthline Media does not provide medical advice, diagnosis, or treatment. Company Announcement.

01-12-2020. Buehler and Hyunh-Ba explain that potency of many drugs can be influenced by “storage conditions,” “pH, light, temperature, and humidity,” and “interactions with excipients and packing materials.” The arrows indiate that the Acella NP Thyroid recall fits within 3 of the 17 reasons for a product recall, since the table had redundancies within it. It is meant to replace a hormone that is usually made by your thyroid gland. This is part 1 of a two-part series reviewing the drug recall notice’s statements and the science behind them.In this post, I put this recall in the context of pharmaceutical guidelines and manufacturing challenges.

“They should continue taking their medication until they can get an appropriate substitute medication from their doctor or their healthcare provider.”© 2005-2020 Healthline Media a Red Ventures Company. Thyroid hormone pharmaceuticals are well known to be very vulnerable to changes in storage conditions.

The FDA has 16 pages of medication lot numbers and expiration dates The medication was distributed nationwide to health care professionals and retail pharmacies.For more information, contact RLC Labs by email to RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid and WP Thyroid because they may be subpotent.Note to readers: if you purchase something through one of our affiliate links we may earn a commission.Registration on or use of this site constitutes acceptance of our Thyroid tablets contain both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine). Next, I’ll get into the potential human RESPONSE to “superpotent” NP Thyroid. The product information for NP Thyroid states clearly that it contains “38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3).” Here is how one could calculate the total “superpotency” per tablet :Therefore, each tablet had 1.02% “superpotency” in micrograms of active ingredient.This error, both in type and degree, should be read in the context of other drug recalls of this nature.The recall was likely due to factors interfering with stability after the product was packaged, not quality control at an earlier phase such as in the mixing of raw ingredients. The FDA allowance for potency in this general category of medication is 90 to 100% of the stated dose, so it was 5% above the specification limit.
Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required.

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, … Acella, the makers of NP Thyroid, issued a voluntary recall notice on May 22, 2020. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.”Both medications contain liothyronine and levothyroxine and were sold in 30, 60, 90, 10 and 1,000 count bottles. The statement that Acella made on May 22, 2020, which “Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The product may have as low as 87 percent of the labeled amount of Liothyronine (T3) or Levothyroxine (T4). They’re not associated with serious adverse reactions.Westminster Pharmaceuticals has recalled the 15, 30, 60, 90, and 120 milligram versions of levothyroxine and liothyronine at wholesale level. NP Thyroid was ethical to specify 115%. Generally, thyroid replacement treatment is to be taken for life. These lots were distributed nationwide in the USA to Westminster’s direct accounts.Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled and to notify their sub-wholesale accounts of this product recall and make arrangements for impacted product to be returned to Westminster.

Wockhardt kept it a secret. They did so because they assumed that potency would be lost, and they compensated for the loss by packing extra T4 into the tablets.Overall, as Lowe states, “the stability of levothyroxine has been far more in question at the FDA than has that of desiccated thyroid.” This is likely because LT4 is now the more commonly prescribed thyroid hormone preparation and has been the focus of intense FDA scrutiny since late 1990s.A recall of a different synthetic LT4 preparation in the UK, a liquid formulation, was announced in January 2020 for a similar reason: Liothyronine (LT3) is considered an “impurity” when the drug is not supposed to have more than 2%.The tablet was not supposed to contain any liothyronine (LT3) at all, yet specifications permitted it to contain a small amount anyway, because LT4 inevitably degrades on the shelf. Updated Sep 09, 2020; Posted Sep 09, 2020 RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid and WP Thyroid because they may be subpotent.