Teva Pharmaceuticals USA has issued an immediate recall of certain lots of Fentanyl Buccal (placed in cheek) Tablets CII due to missing information in the product insert. Lack of proper safety information within the insert can lead to serious health ramifications due to mis-use by consumers. As of the writing of this notice, no adverse events have yet been reported.
SUMMARY
Date of Recall:
Announced: April 27, 2023
Public Notification: April 28, 2023
Name(s) of Drug:
Fentanyl Buccal Tablets CII
Company Name:
Mayne Pharma, Inc. (brand)
Teva Pharmaceuticals USA (manufacturer)
Drug Indication:
Pain
Product Description
Product is packaged in white boxes with a single orange, green, blue, pink or yellow stripe. The box contains 7 cards, each containing 4 tablets. Each tablet within the card is encased in a foil lined, childproof blister. Each tablet is a flat, white, round tablet debossed with a “C” on one side and a 1, 2, 4, 6 or 8 on the other.
Reason for Recall
Updates made to the products insert and medication guide were omitted and potentially leave room for the consumer to receive mis-information that can lead to improper use of this potentially dangerous medication.
Impacts
Consumers who receive mis-information could potentially receive an incorrect dose of the medication. Receiving less than prescribed doses of the medication could lead to continued symptoms or symptoms of withdrawal (see below). For consumers receiving more than the prescribed dose, symptoms could include:
- Pinpoint Pupils
- Slurred Speech
- Inability to Walk Properly
- Falling Asleep
- Loss of Consciousness
- Cold, Clammy Skin
- Slowed Breathing
- Complete Lack of Breathing
- Death
Lot information
Consumers should locate the box in which the medication comes to compare NDC and lot numbers as well as expiration dates, strength, and size with the chart below. If you find your NDC number, lot number, strength, size and expiration date on the chart below, your medication is affected by the recall and you will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.
| NDC# | Lot | Exp. Date | Strength | Size |
| 51862-634-28 | 42617828 | 06/2023 | 100 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-634-28 | 100020465 | 01/2024 | 100 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-635-28 | 100020528 | 09/2024 | 200 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-635-28 | 100026699 | 11/2024 | 200 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-636-28 | 100020351 | 11/2024 | 400 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-636-28 | 100020522 | 09/2024 | 400 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-636-28 | 100026700 | 11/2024 | 400 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-637-28 | 42617831 | 06/2023 | 600 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-637-28 | 42619585 | 11/2023 | 600 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-637-28 | 100029649 | 11/2024 | 600 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-638-28 | 42617832 | 06/2023 | 800 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-638-28 | 42619530 | 08/2023 | 800 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
| 51862-638-28 | 100020532 | 11/2024 | 800 mcg | 28 Buccal Tablets (4 Tablets x 7 Cards) (4 tablets x 7 cards) |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY. SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.
Discontinuation of this medication may cause return of pain symptoms or symptoms of Fentanyl withdrawal. These may include:
- Diarrhea
- Sweating
- Insomnia
- Dilated Pupils
- Nausea
- Sweating
- Fever
- Intense Cravings for Fentanyl
If you find that your lot of medication is part of this recall, do the following:
- Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
- Notify your physician of any change in your health.
- Once you have obtained a replacement for your medication, Teva is asking that you return any unused portion of the medication. Consumers should contact Teva at 1-855-246-5024 or via email at rxrecalls@inmar.com for assistance with returns.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately. Once you have sought medical assistance, please notify the pharmaceutical company at 1-888-483-8279 or contact them via email at USMedInfo@tevapharm.com. You may also notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact IBSA Pharma Inc at 1-855-246-5024 or via email at rxrecalls@inmar.com. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Contact IBSA Pharma Inc at 1-855-246-5024 or via email at rxrecalls@inmar.com. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.
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