Why was this medication recalled??

Question

i went to a pharmacy today to pick up some medication for my family. i was told that Hyoscyamine was no longer made. so i googled "Hyoscyamine recall" and i was brought to the FDA website and it said this:

PRODUCT Hyoscyamine Sulfate, USP Timed-Release Capsules, 0.375 mg, in 100 capsule bottles, Rx drug indicated for various uses including, control of gastric secretion, visceral spasm and hypermotility. Recall #D-011-5.

CODE Lot numbers: 27001 EXP 7/95, 27002 EXP 11/95, HS403 EXP 2/96.

MANUFACTURER Eros Pharma PVT., Ltd., Bangalore, India.

RECALLED BY Econolab, Inc., Westland, Michigan, by letter October 7, 1994. Firm-initiated recall ongoing.

DISTRIBUTION Nationwide.

QUANTITY 1,487 bottles of lot 27001, 5,298 bottles of lot 27002, and 3,439 bottles of lot HS403 were distributed.

REASON Product fails dissolution specification.

ok, but i don't get the REASON for it being recalled. can someone explain the reason in a simple way?

Answer 1

Those recall dates are from the 1990s and only affected one batch.

Hyoscamine is perhaps prohibited for over the counter sales now because it's dangerous, or being misused by idiots to get high.

As a prescription drug, it's useful.

Answer 2

You have it in the last line:

REASON Product fails dissolution specification.

Medicines are subject to very tight controls.  When they are being manufactured, many of the qualities of a pill, for example, are set out in detailed specifications.  A pill taken by mouth should dissolve in a certain amount of time, or it will be eliminated before it is absorbed in the bloodstream.

This batch run didn't dissolve fast enough, so they pulled it.

Answer 3

Reason: either dissolved too slowly, or too quickly.

Just that batch is affected.

Stay aware of recalls at

http://www.totalrecallinfo.com

Take care.