BALTIMORE -- Officials with Lupin Pharmaceuticals have announced that some of their oral contraceptives may have packaging errors that could result in misuse - and unintended pregnancy.
A confirmed market complaint indicates that packaging errors on some blister packs of Mibelas 24 Fe tablets were rotated 180 degrees within the "wallet" reversing the weekly tablet orientation. Part of the issue with this is that the first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.
"As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy," a Food and Drug Administration statement said.
The statement explains that the error is subtle enough that it may not be apparent to new or previous users of the product. They add that in certain women, a pregnancy could lead to adverse maternal or fetal health consequences - including death.
The error also makes it hard to see the lot number and expiration date. Packaging details include the following:
68180-911-11 (Wallet of 28 tablets) |
68180-911-13 (Carton of 3 wallets)
These products are packaged in blister packs containing 28 tablets: 24 white to off-white tablets of active ingredients debossed with “LU” on one side and “N81” on the other; and 4 tablets of inert ingredients debossed with “LU” on one side and “M22” on the other side.
Consumers with questions regarding this recall can contact Lupin by phone 1-800-399-2561, 8 a.m. to 5 p.m., Monday through Friday.
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