Why it was recalled
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Product description
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Lot numbers, UPCs & expiration codes
Lot#: 503670
Where it was sold
Nationwide USA
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-0094-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2021
- FDA report date
- Nov 17, 2021
- Quantity
- 166,920 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Precision Dose Inc.
Original FDA data
Every field from FDA enforcement report D-0094-2022, exactly as published.
Show all FDA fields
- City
- South Beloit
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88976
- Address
- 722 Progressive Ln
- Code information
- Lot#: 503670
- Postal code
- 61080-2616
- Report date
- Nov 17, 2021
- Product type
- Drugs
- Recall number
- D-0094-2022
- Classification
- Class II
- Recalling firm
- Precision Dose Inc.
- Product quantity
- 166,920 unit dose cups
- Termination date
- Jul 14, 2024
- Reason for recall
- cGMP Deviations: Product manufactured with contaminated raw ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Nov 1, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2021