Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
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
Lot numbers, UPCs & expiration codes
Lot # AF4273A; Exp. 02/18
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0128-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 8, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 19,944 Cartons (24 tablets each)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- L. Perrigo Company
Original FDA data
Every field from FDA enforcement report D-0128-2018, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 78520
- Address
- 515 Eastern Ave
- Code information
- Lot # AF4273A; Exp. 02/18
- Postal code
- 49010-9070
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0128-2018
- Classification
- Class II
- Recalling firm
- L. Perrigo Company
- Product quantity
- 19,944 Cartons (24 tablets each)
- Termination date
- Dec 13, 2018
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 8, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 21, 2017