Perrigo Recalls Zephrex-D Nasal Decongestant Due to Microbial Contamination
L. Perrigo Company is recalling Zephrex-D nasal decongestant softgels due to microbial contamination. Consumers should stop using the product and return it to the pharmacy.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a significant hazard such as microbial contamination is categorized as Severe (Score 4).
Plain-English summary
L. Perrigo Company is recalling 19,944 cartons of Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. The product is distributed in 24 softgel tablet paper cartons under NDC 70085-151-01. The recall is limited to Lot # AF4273A with an expiration date of 02/18.
The recall was initiated due to microbial contamination of the non-sterile product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide. Consumers who have this specific lot of Zephrex-D should stop using it and return it to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- 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
- Manufacturer
- L. Perrigo Company
- Category
- Drug — Nasal Decongestant
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AF4273A
- Exp. 02/18
Distribution
Distributed nationwide across the United States.
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