CLASS III Drug recall · Reported 15 Apr 2015 · FDA Enforcement Report
Promethazine VC With Codeine Syrup, Each contains recalled
Qualitest Pharmaceuticals is recalling Promethazine VC With Codeine Syrup, Each contains: Codeine Phosphate 10 mg, Promethazine, distributed nationwide in the US. The recall was initiated on 25 Mar 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D00432-2015
- FDA event ID
- 70852
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Mar 2015
- FDA classified
- 6 Apr 2015
- Reported
- 15 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cold & Cough Medicine
Timeline
| 25 Mar 2015 | Recall initiated by company | |
| 6 Apr 2015 | Classified by FDA | +12 days |
| 15 Apr 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
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 was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Qualitest Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Allopurinol Tablets, USP, 300 mg recalled by Qualitest PharmaceuticalsAllopurinol | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Disulfiram tablets, USP, 500 mg recalled by Qualitest Pharmaceuticals | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Promethazine DM Syrup (Promethazine Hydrochloride recalled | Qualitest Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Amlodipine Besylate Tablets USP, 10 mg* bottles recalled | Qualitest Pharmaceuticals | Other | Nationwide |