Class II
Terminated
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
This recall has been terminated (originally issued November 17, 2021).
- Company
- Precision Dose Inc.
- Recall Initiated
- November 1, 2021
- Posted
- November 17, 2021
- Recall Number
- D-0095-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 151,100 unit dose cups
- Firm Location
- South Beloit, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Distribution
Nationwide USA
Lot / Code Info
Lot#: 503679, 503693, 503715
More recalls by Precision Dose Inc.
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case...
Jan 20, 2021 · Class II
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62;...
Mar 18, 2020 · Class II
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in...
Nov 8, 2017 · Class III
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026