Class II · Moderate risk
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Aldactone (spironolactone)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31
Affected NDC
0025-1031-31
Compare with the code on your package — it is the most precise check available.
Drug: Iron
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 |
|---|---|---|---|---|
| Aldactone spironolactone NDC 00025-1031 |
100 mg/1 | Tablet, Film Coated Oral |
Pfizer Laboratories Div Pfizer Inc | Rx |
- Recalling firm
- Pfizer Us Pharmaceutical Group
- NDC code
- 0025-1031-31
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-014-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iron recalls
See all
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Ferrous Sulfate Iron Supplement Drops
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Pfizer Us Pharmaceutical Group
All 2013 recalls
Class II · Moderate risk
Pristiq (desvenlafaxine)
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Class I · High risk
Effexor XR
Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
Class III · Low risk
Advil PM Caplets
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
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