Teva Recalls Actiq Fentanyl Lozenges Due to Dissolution Failure
Teva Pharmaceuticals is recalling 316 cartons of Actiq 200 mcg fentanyl lozenges because they failed dissolution specifications during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant potential health risks, such as failure to meet dissolution specifications for a potent opioid medication.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 316 cartons of Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick. The affected product includes single blisters (NDC 63459-502-01) and 30-count cartons (NDC 63459-502-30). The specific lot number is C88583, with an expiration date of 06/15. The product was manufactured by Cephalon, Inc., in Salt Lake City, Utah.
The recall was initiated because the product failed dissolution specifications during stability testing. This indicates that the medication may not release the active ingredient at the intended rate, potentially affecting its efficacy or safety profile.
The product was distributed within the United States to Florida, Illinois, Massachusetts, Missouri, Mississippi, Ohio, and Texas. There was no distribution to government or foreign entities. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on replacement or disposal.
The recalled product
- Product
- Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Opioid Analgesic
- Hazard
- Affected units
- 316
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot C88583
- exp. 06/15
Distribution
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