CLASS II Drug recall · Reported 27 Dec 2017 · FDA Enforcement Report
Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg recalled
L. Perrigo is recalling Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant, distributed nationwide in the US. The recall was initiated on 8 Nov 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-0128-2018
- FDA event ID
- 78520
- Recalling firm
- L. Perrigo, Allegan, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2017
- FDA classified
- 21 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Nasal Sprays
Timeline
| 8 Nov 2017 | Recall initiated by company | |
| 21 Dec 2017 | Classified by FDA | +43 days |
| 27 Dec 2017 | 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
Microbial Contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01
Where it was distributed
Nationwide
Questions about this recall
Is Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant recalled?
Yes. L. Perrigo recalled Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant on 8 Nov 2017. The recall is Class II and its status is Terminated. Recall number D-0128-2018.
Why was it recalled?
Microbial Contamination of Non-Sterile Products
Which lots are affected?
Lot # AF4273A; Exp. 02/18
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 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 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.
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