Why it was recalled
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Product description
Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16
Lot numbers, UPCs & expiration codes
X110042, X110051, X110064, Exp 09/13
Where it was sold
Nationwide & Puerto Rico
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-006-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 14, 2012
- FDA report date
- Oct 17, 2012
- Quantity
- 19,980 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Mid Atlantic LLC
Original FDA data
Every field from FDA enforcement report D-006-2013, exactly as published.
Show all FDA fields
- City
- Lincolnton
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 62827
- Address
- 1877 Kawai Rd
- Code information
- X110042, X110051, X110064, Exp 09/13
- Postal code
- 28092-5905
- Report date
- Oct 17, 2012
- Product type
- Drugs
- Recall number
- D-006-2013
- Classification
- Class III
- Recalling firm
- Actavis Mid Atlantic LLC
- Product quantity
- 19,980 Bottles
- Termination date
- Jun 27, 2013
- Reason for recall
- Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16
- Distribution pattern
- Nationwide & Puerto Rico
- Recall initiation date
- Aug 14, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2012