Class II · Moderate risk
Levothyroxine Sodium Tablets
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Macrobid Urinary Tract Anitbacterial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01
Affected NDC
52427-0285-01
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Macrobid Nitrofurantoin Monohydrate/Macrocrystalline NDC 52427-0285 |
NITROFURANTOIN 25 mg/1; NITROFURANTOIN MONOHYDRATE 75 mg/1 | Capsule Oral |
Almatica Pharma LLC | Rx |
- Recalling firm
- Alvogen, Inc
- NDC code
- 52427-285-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1723-2019 · 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 recalls by Alvogen, Inc
All 2019 recalls
Class I · High risk
Fentanyl Transdermal System CII
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Other dissolution failure recalls from 2019
All dissolution failure recalls
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class II · Moderate risk
Raloxifene Hydrochloride Tablets
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Class II · Moderate risk
Prasugrel Tablets 5 mg
Failed Dissolution Specification: Low out of specification dissolution results.
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