CLASS III Drug recall · Reported 11 May 2016 · FDA Enforcement Report
Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg recalled
A-S Medication Solutions is recalling Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, distributed in Virginia. The recall was initiated on 22 Apr 2016 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
- D-0839-2016
- FDA event ID
- 74011
- Recalling firm
- A-S Medication Solutions, Libertyville, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Apr 2016
- FDA classified
- 5 May 2016
- Reported
- 11 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 22 Apr 2016 | Recall initiated by company | |
| 5 May 2016 | Classified by FDA | +13 days |
| 11 May 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not elsewhere classified - count on the label was incorrect.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
Where it was distributed
Virginia
Questions about this recall
Is Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg recalled?
Yes. A-S Medication Solutions recalled Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg on 22 Apr 2016. The recall is Class III and its status is Terminated. Recall number D-0839-2016.
Why was it recalled?
Labeling: Not elsewhere classified - count on the label was incorrect.
Which lots are affected?
Lot # 6050129, Exp 05/31/17
Where was it sold?
Virginia
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 21 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 A-S Medication Solutions
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|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS I | Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen | A-S Medication Solutions | Labeling Errors | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |
| Drug | CLASS I | Acetaminophen, Extra Strength, Aspirin Free, Mfr recalledAcetaminophen | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Valsartan Tablets, 160 MG bottle recalled by A-S Medication Solutions | A-S Medication Solutions | Potency & Assay | Nationwide |