Class III
Terminated
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.
This recall has been terminated (originally issued April 15, 2015).
- Company
- Qualitest Pharmaceuticals
- Recall Initiated
- March 25, 2015
- Posted
- April 15, 2015
- Recall Number
- D00432-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 36,732 units
- Firm Location
- Huntsville, AL, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Lot #: (a) L073D14A, Exp 07/31/15. Lot #: (b) L073D14B, Exp 07/31/15; 0000002247, Exp 03/31/16; L063B14A, Exp 05/31/15
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