Actavis Recalls Subpotent Gelnique Oxybutynin Chloride Gel Samples
Actavis is recalling Gelnique (oxybutynin chloride) Gel 10% physician samples because drug potency was compromised during shipment.
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 is defined as unlikely to cause adverse health consequences. The hazard is subpotency (reduced efficacy) rather than toxicity or contamination, fitting the Moderate severity criteria for low-risk issues.
Plain-English summary
Actavis is recalling 38,227 clamshells of Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. The product is a prescription-only physician sample distributed nationwide to physicians. The recall is due to compromised drug potency during shipment.
The affected product is identified by Lot # 514656 and an expiration date of 03/14. The manufacturer is Watson Pharmaceuticals Inc, Corona, CA. The recall number is D-1088-2014.
Physicians who received these samples should stop using them and contact Actavis for instructions on return or disposal. Patients who have already used the product should consult their healthcare provider.
The recalled product
- Product
- Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.
- Manufacturer
- Actavis
- Category
- Drug — Topical Gel
- Hazard
- Affected units
- 38,227
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 #: 514656
- Expiry: 03/14
Distribution
Distributed nationwide across the United States.
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