Teligent Pharma Recalls Flurandrenolide Ointment Due to Impurity Failures
Teligent Pharma is recalling 3,432 tubes of Flurandrenolide Ointment 0.05% because the product failed impurity and degradation specifications.
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 severity score under the rubric for drug recalls.
Plain-English summary
Teligent Pharma, Inc. is recalling 3,432 tubes of Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams. The product is identified by NDC 52565-017-60, Lot #13974, and an expiration date of 7/2021.
The recall was initiated because the product failed impurities and degradation specifications. The affected units were distributed nationwide in the USA.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 3,432
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 (1)
- Lot #13974 EXP 7/2021
Distribution
Distributed nationwide across the United States.
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