Class II · Moderate risk
Atropine Sulfate injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Donnatal
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
Affected NDC
59212-0425-10
Compare with the code on your package — it is the most precise check available.
Drug: Atropine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide NDC 59212-0425 |
PHENOBARBITAL 16.2 mg/1; HYOSCYAMINE SULFATE .1037 mg/1; ATROPINE SULFATE .0194 mg/1; SCOPOLAMINE HYDROBROMIDE .0065 mg/1 | Tablet Oral |
Advanz Pharma (US) Corp. | Rx · CIV |
- Recalling firm
- Rx PAK
- NDC code
- 59212-425-10
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0053-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Atropine recalls
See all
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
Class I · High risk
Atropine Sulfate Injection
Presence of Particulate Matter; identified as glass
Class II · Moderate risk
Atropine Sulfate Injection
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other labeling / mix-up recalls from 2015
All labeling / mix-up recalls
Class III · Low risk
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Class III · Low risk
Lumizyme (alglucosidase alpha)
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
NABUMETONE Tablets USP
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class II · Moderate risk
Rocuronium Bromide 50 MG/5ML INJ.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
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