CLASS II Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg recalled
Pharmatech is recalling Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, distributed in Michigan. The recall was initiated on 16 Aug 2017 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-0227-2018
- FDA event ID
- 77960
- Recalling firm
- Pharmatech, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Aug 2017
- FDA classified
- 17 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Allergy Medication
Timeline
| 16 Aug 2017 | Recall initiated by company | |
| 17 Jan 2018 | Classified by FDA | +154 days |
| 24 Jan 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Product as listed by the FDA
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL
Where it was distributed
MI
Questions about this recall
Why was it recalled?
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
MI
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
3 other products · FDA event 77960More recalls from Pharmatech
All 53| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Rugby Poly-Vitamin w/ Iron Liquid recalled by PharmatechRugby Poly-Vitamin | Pharmatech | Mold | MI |
| Food | CLASS II | Rugby Cerovite Liquid recalled by PharmatechRugby Cerovite | Pharmatech | Mold | MI |
| Food | CLASS II | Major Poly-Vita Drops w/ Iron recalled by PharmatechMajor Poly-Vita | Pharmatech | Mold | MI |
| Food | CLASS II | Rugby Liquid Vitamin C Supplement 500 mg recalled by PharmatechRugby | Pharmatech | Mold | MI |
| Food | CLASS II | Rugby Tri-Vitamin Liquid recalled by PharmatechRugby Tri-Vitamin | Pharmatech | Mold | MI |
Other Rugby Aller-chlor (chlorpheniramine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg recalled | The Harvard Drug Group | Mold | Nationwide |