Why it was recalled
Defective container: Out of specification for container integrity leading to bottles leaking.
Product description
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Lot numbers, UPCs & expiration codes
Lot #: E1220B
Where it was sold
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
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-0278-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 29, 2021
- FDA report date
- Dec 22, 2021
- Quantity
- 72 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0278-2022, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 89143
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: E1220B
- Postal code
- 92807-1801
- Report date
- Dec 22, 2021
- Product type
- Drugs
- Recall number
- D-0278-2022
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 72 bottles
- Reason for recall
- Defective container: Out of specification for container integrity leading to bottles leaking.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
- Distribution pattern
- Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
- Recall initiation date
- Nov 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 13, 2021