Why it was recalled
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Product description
PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.
Lot numbers, UPCs & expiration codes
Lot #: (a) L073D14A, Exp 07/31/15. Lot #: (b) L073D14B, Exp 07/31/15; 0000002247, Exp 03/31/16; L063B14A, Exp 05/31/15
Where it was sold
Nationwide
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
- D00432-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 25, 2015
- FDA report date
- Apr 15, 2015
- Quantity
- 36,732 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D00432-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 70852
- Address
- 120 Vintage Dr NE
- Code information
- Lot #: (a) L073D14A, Exp 07/31/15. Lot #: (b) L073D14B, Exp 07/31/15; 0000002247, Exp 03/31/16; L063B14A, Exp 05/31/15
- Postal code
- 35811-8216
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D00432-2015
- Classification
- Class III
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 36,732 units
- Termination date
- Jul 12, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 25, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2015