Why it was recalled
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Product description
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
Lot numbers, UPCs & expiration codes
Lot #: 14049A, Exp 12/21
Where it was sold
Nationwide in the USA
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-1279-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 25, 2019
- FDA report date
- May 8, 2019
- Quantity
- 111,492 canisters total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advantice Health
Original FDA data
Every field from FDA enforcement report D-1279-2019, exactly as published.
Show all FDA fields
- City
- Cedar Knolls
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82709
- Address
- 7 E Frederick Pl Ste 100
- Code information
- Lot #: 14049A, Exp 12/21
- Postal code
- 07927-1815
- Report date
- May 8, 2019
- Product type
- Drugs
- Recall number
- D-1279-2019
- Classification
- Class III
- Recalling firm
- Advantice Health
- Product quantity
- 111,492 canisters total
- Termination date
- Feb 11, 2021
- Reason for recall
- Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 25, 2019
- Initial firm notification
- Letter
- Center classification date
- May 14, 2019