Why it was recalled
Subpotent Drug: Drug potency was compromised during shipment.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 514656; Expiry: 03/14
Where it was sold
Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1088-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 7, 2014
- FDA report date
- Mar 5, 2014
- Quantity
- 38,227 Clamshells
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis
Original FDA data
Every field from FDA enforcement report D-1088-2014, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 67457
- Address
- 575/577/579 Chipeta Way
- Code information
- Lot #: 514656; Expiry: 03/14
- Postal code
- 84108-1222
- Report date
- Mar 5, 2014
- Product type
- Drugs
- Recall number
- D-1088-2014
- Classification
- Class III
- Recalling firm
- Actavis
- Product quantity
- 38,227 Clamshells
- Termination date
- Sep 5, 2014
- Reason for recall
- Subpotent Drug: Drug potency was compromised during shipment.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed nationwide to physicians as samples. No military/ govt/ VA or foreign consignees.
- Recall initiation date
- Feb 7, 2014
- Initial firm notification
- Letter
- Center classification date
- Feb 25, 2014