Why it was recalled
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Product description
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
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-1506-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 21, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 2052 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharma-Natural Inc.
Original FDA data
Every field from FDA enforcement report D-1506-2019, exactly as published.
Show all FDA fields
- City
- Miami Lakes
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83190
- Address
- 14500 Nw 60th Ave Bldg 7f
- Code information
- All lots remaining within expiry.
- Postal code
- 33014
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1506-2019
- Classification
- Class II
- Recalling firm
- Pharma-Natural Inc.
- Product quantity
- 2052 bottles
- Termination date
- Oct 27, 2021
- Reason for recall
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
- Distribution pattern
- Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Jun 21, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 23, 2019