CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled
Prescript Pharmaceuticals is recalling Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers, distributed in California. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.
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-0809-2018
- FDA event ID
- 79961
- Recalling firm
- Prescript Pharmaceuticals, Pleasanton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2018
- FDA classified
- 14 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 24 Apr 2018 | Recall initiated by company | |
| 14 May 2018 | Classified by FDA | +20 days |
| 23 May 2018 | 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
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
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 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834
Where it was distributed
California.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Which lots are affected?
Lot # 0130130 EXP 12/31/20
Where was it sold?
California.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
4 other products · FDA event 79961This product is part of a recall event; the main page for the event is Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalledAcetaminophen And Codeine Phosphate | Prescript Pharmaceuticals | Other | CA | |
| CLASS II | Chlorhexidine 0.12% liquid, 473 Milliters recalled | Prescript Pharmaceuticals | Other | CA | |
| CLASS II | Clindamycin, USP M-Pak container recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA | |
| CLASS II | Clindamycin, USP M-Pak containers recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA |
More recalls from Prescript Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin, USP M-Pak containers recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA |
| Drug | CLASS II | Clindamycin, USP M-Pak container recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA |
| Drug | CLASS II | Chlorhexidine 0.12% liquid, 473 Milliters recalled | Prescript Pharmaceuticals | Other | CA |
| Drug | CLASS II | Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalledAcetaminophen And Codeine Phosphate | Prescript Pharmaceuticals | Other | CA |
Other Acetaminophen recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |