Why it was recalled
Lack of Processing Controls.
Product description
Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
Lot numbers, UPCs & expiration codes
N/A
Where it was sold
TN only
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-0419-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2018
- FDA report date
- Feb 6, 2019
- Quantity
- 876 cc
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Duren Health Mart Pharmacy
Original FDA data
Every field from FDA enforcement report D-0419-2019, exactly as published.
Show all FDA fields
- City
- Waynesboro
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 81811
- Address
- 215 Dexter L Woods Memorial Blvd
- Postal code
- 38485-2416
- Report date
- Feb 6, 2019
- Product type
- Drugs
- Recall number
- D-0419-2019
- Classification
- Class II
- Recalling firm
- Duren Health Mart Pharmacy
- Product quantity
- 876 cc
- Termination date
- Jan 19, 2022
- Reason for recall
- Lack of Processing Controls.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
- Distribution pattern
- TN only
- Recall initiation date
- Dec 17, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 28, 2019