Why it was recalled
Microbial Contamination of Non-Sterile Product.
Product description
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
Lot numbers, UPCs & expiration codes
Lot: WBD003 Exp. 03/21
Where it was sold
Distributed in MI and further distributed 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-0126-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 18, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 31,392 30 mL bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GCP Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-0126-2020, exactly as published.
Show all FDA fields
- City
- Gulfport
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 83835
- Address
- 3600 25th Ave
- Code information
- Lot: WBD003 Exp. 03/21
- Postal code
- 39501-6922
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0126-2020
- Classification
- Class II
- Recalling firm
- GCP Laboratories Inc
- Product quantity
- 31,392 30 mL bottles
- Termination date
- Feb 5, 2021
- Reason for recall
- Microbial Contamination of Non-Sterile Product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
- Distribution pattern
- Distributed in MI and further distributed Nationwide.
- Recall initiation date
- Sep 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 7, 2019