Actavis Recalls Subpotent Flurandrenolide Tape Products Nationwide
Actavis is recalling Flurandrenolide Tape products because the active ingredient is subpotent. The recall covers 78,522 cartons distributed in the U.S. and U.K.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is subpotency, which is a quality defect rather than a direct physical or toxicological hazard.
Plain-English summary
Actavis Laboratories is recalling 78,522 cartons of Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. The products are distributed by Actavis Pharma, Inc., and manufactured by 3M Company. The recall includes products labeled as Cordran Tape (Small and Large Rolls) and Haelan Tape (Fludroxycortide) Bulk Rolls.
The recall was initiated because the flurandrenolide in the affected products is subpotent, meaning it contains less than the labeled amount of the active ingredient. The affected lots have an expiration date of JAN-2016.
The products were distributed nationwide in the United States, including Puerto Rico, as well as in the United Kingdom. Patients and healthcare providers should stop using the affected products and contact their healthcare provider for further instructions.
The recalled product
- Product
- Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 i
- Manufacturer
- Actavis Laboratories
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 78,522
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 (14)
- A) Lots: 266142A
- 843021
- 845760
- 853846
- 893193
- 900634
- Expiry: JAN-2016. B) Lots: 266142D
- 822241
- 853847
- 862000
- 874337
- 893209
- Expiry: JAN-2016. C) Lot: 266142C
- Expiry: JAN-2016.
Distribution
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