Recent FDA Drug and Medical Device Recalls
Washington, D.C. — October 5, 2001 — Recent recalls of various drugs and
medical devices by the Food and Drug Administration (FDA) include Glyburide tablets (for diabetes), Deltasone
tablets (prednisone, an anti–inflammatory medication), Acetaminophen (used to treat children’s
headaches and fevers), and certain hip implant components. All dosages of Baycol/Lipobay, a cholesterol–lowering
drug, have been withdrawn from the market due to side effects such as muscular weakness, which may prove
fatal in some elderly patients.
The brand names and details of these recalls and withdrawals are listed below.
For a complete list of recent FDA actions, see the agency’s
web site.
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on
a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal
action. The firm removes the product from the market or corrects the violation. For example, a product
removed from the market due to tampering, without evidence of manufacturing or distribution problems,
would be a market withdrawal.
Drug or Medical Device |
Lot, Manufacturer |
Glyburide tablets
Fungal organisms have been detected in some lots. |
Micronase lots 84DWB (1.25 mg, bottle of 100); 91DYR (2.5 mg, bottle of 100); 67FPP
(5 mg, bottle of 100); and 42 different lots of Greenstone Brand. |
Deltasone tablets (prednisone)
Bottles labeled to contain 10 mg, actually may actually contain, 5 mg. |
Pharmacia Corporation announced a US recall of its 500 count bottles of Deltasone
Tablets (prednisone tablets, USP), 10 mg, Lot number 29DRB. |
Acetaminophen
May contain up to 29 percent over the labeled amount. Overdoses can cause liver toxicity. Product
is used to treat headaches and fevers in children. |
Perrigo Company recall of four–ounce bottles of cherry–flavored pain
reliever suspension liquid with Lot Number 1AD0228; sold under the Good Sense®,
Hy–Vee®, and Kroger® labels throughout the United States. |
Baycol (cerivastatin)
Cholesterol–lowering drug may cause muscular weakness (rhabdomyolysis). |
Withdrawal of all dosages of Baycol/Lipobay. |
Zirconia ceramic femoral head (for hip implants)
The component is the ball portion of the hip prosthesis that connects the femoral stem to the
pelvis Hip implant fractured at a higher rate than expected. |
French manufacturer St. Gobain Desmarquest distributes worldwide. French recall
applies to nine batches of zirconia ceramic femoral heads manufactured since early 1998.
The affected batches have the prefix “TH” before the batch number. |
