US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.

What was recalled

PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-718-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Atropine recalls

See all
Class III · Low risk Terminated

Atropine Sulfate Ophthalmic Solution

Reason Failed Impurities/Degradation Specifications

Somerset Therapeutics LLC NDC 70069-716-01 D-0169-2025
Class I · High risk Ongoing

Atropine Sulfate Injection

Reason Presence of Particulate Matter; identified as glass

Pfizer Inc. NDC 0409-4911-11 D-0235-2024
Class II · Moderate risk Terminated

Atropine Sulfate Injection

Reason Presence of Particulate Matter: Particulate matter identified as fiber.

Accord Healthcare, Inc. NDC 16729-512-43 D-0917-2023
Class II · Moderate risk Ongoing

Atropine Sulfate Ophthalmic Solution

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0779-2023
Class III · Low risk Ongoing

Atropine Sulfate Ophthalmic Solution

Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Akorn, Inc. D-0265-2023